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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Alpha-linolenic acid (ALA) ALA contributes to the The claim may be used only for food maintenance of normal 2009;7(9):1252, maintenance of normal which is at least a source of ALA as blood cholesterol 2011;9(6):2203 blood cholesterol levels referred to in the claim SOURCE OF concentrations OMEGA 3 FATTY ACIDS as listed in the Annex to Regulation (EC) No 1924/2006. Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 2 g of ALA.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

493, 568

Art.13(1) Activated charcoal

Activated charcoal contributes to reducing excessive flatulence after eating

The claim may be used only for food reduction of excessive 2011;9(4):2049 which contains 1 g of activated intestinal gas charcoal per quantified portion. In accumulation order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with 1 g which should be taken at least 30 minutes before and 1 g shortly after the meal.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1938

Art.13(1) Barley grain fibre

Barley grain fibre The claim may be used only for food increase in faecal bulk 2011;9(6):2249 contributes to an which is high in that fibre as referred to increase in faecal bulk in the claim HIGH FIBRE as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

819

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta-glucans

Beta-glucans contribute to the maintenance of normal blood cholesterol levels

The claim may be used only for food maintenance of normal 2009;7(9):1254, which contains at least 1 g of betablood cholesterol 2011;9(6):2207 glucans from oats, oat bran, barley, concentrations barley bran, or from mixtures of these sources per quantified portion. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of beta-glucans from oats, oat bran, barley, barley bran, or from mixtures of these beta-glucans.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

754, 755, 757, 801, 1236, 1299, 1465, 2934

Art.13(1) Betaine

Betaine contributes to normal homocysteine metabolism

The claim may be used only for food contribution to normal which contains at least 500 mg of homocysteine betaine per quantified portion. In order metabolism to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 1,5 g of betaine.In order to bear the claim information shall be given to the consumer that a daily intake in excess of 4 g may significantly increase blood cholesterol levels. In order to bear the claim information shall be given to the consumer that a daily intake in excess of 4 g may significantly increase blood cholesterol levels.

2011;9(4):2052

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

4325

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Biotin

Biotin contributes to The claim may be used only for food normal energy-yielding which is at least a source of biotin as metabolism referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

energy-yielding metabolism

2009;7(9):1209

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

114, 117

Art.13(1) Biotin

Biotin contributes to normal functioning of the nervous system

The claim may be used only for food which is at least a source of biotin as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

function of the nervous 2009;7(9):1209 system

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

116

Art.13(1) Biotin

Biotin contributes to normal macronutrient metabolism

The claim may be used only for food which is at least a source of biotin as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

contribution to normal macronutrient metabolism

2009;7(9):1209, 2010;8(10):1728

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

113, 114, 117, 4661

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is at least a source of biotin as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Biotin

Biotin contributes to normal psychological function

contribution to normal 2010;8(10):1728 psychological functions

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

120

Art.13(1) Biotin

Biotin contributes to the The claim may be used only for food maintenance of normal which is at least a source of biotin as hair referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of normal 2009;7(9):1209, hair 2010;8(10):1728

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

118, 121, 2876

Art.13(1) Biotin

Biotin contributes to the The claim may be used only for food maintenance of normal which is at least a source of biotin as mucous membranes referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of normal 2009;7(9):1209 skin and mucous membranes

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

115

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Biotin

Biotin contributes to the The claim may be used only for food maintenance of normal which is at least a source of biotin as skin referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of normal 2009;7(9):1209, skin and mucous 2010;8(10):1728 membranes

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

115, 121

Art.13(1) Calcium

Calcium contributes to The claim may be used only for food blood coagulation normal blood clotting which is at least a source of calcium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1210

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

230, 236

Art.13(1) Calcium

Calcium contributes to The claim may be used only for food energy-yielding normal energy-yielding which is at least a source of calcium as metabolism metabolism referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1210

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

234

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Calcium

Calcium contributes to The claim may be used only for food muscle function and normal muscle function which is at least a source of calcium as neurotransmission referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1210

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

226, 230, 235

Art.13(1) Calcium

Calcium contributes to The claim may be used only for food muscle function and normal which is at least a source of calcium as neurotransmission neurotransmission referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1210

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

227, 230, 235

Art.13(1) Calcium

Calcium contributes to The claim may be used only for food function of digestive the normal function of which is at least a source of calcium as enzymes digestive enzymes referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1210

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

355

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Calcium

Calcium has a role in the process of cell division and specialisation

The claim may be used only for food regulation of cell which is at least a source of calcium as division and referred to in the claim SOURCE OF differentiation [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1725

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

237

Art.13(1) Calcium

Calcium is needed for the maintenance of normal bones

The claim may be used only for food maintenance of normal which is at least a source of calcium as bones and teeth referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1210, 2009;7(9):1272, 2010;8(10):1725, 2011;9(6):2203

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

Art.13(1) Calcium

Calcium is needed for the maintenance of normal teeth

The claim may be used only for food maintenance of normal 2009;7(9):1210, which is at least a source of calcium as bones and teeth 2010;8(10):1725, referred to in the claim SOURCE OF 2011;9(6):2203 [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

224, 230, 350, 354, 2731, 3155, 4311, 4312, 4703, 4704 224, 230, 231, 2731, 3099, 3155, 4311, 4312, 4703, 4704

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate-electrolyte solutions

CarbohydrateIn order to bear the claim carbohydrate maintenance of 2011;9(6):2211 electrolyte solutions -electrolyte solutions should contain 80 endurance performance contribute to the 350 kcal/L from carbohydrates, and at maintenance of least 75 % of the energy should be endurance performance derived from carbohydrates which during prolonged induce a high glycaemic response, endurance exercise such as glucose, glucose polymers and sucrose. In addition, these beverages should contain between 20 mmol/L (460 mg/L) and 50 mmol/L (1,150 mg/L) of sodium, and have an osmolality between 200 330 mOsm/kg water.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

466, 469

Art.13(1) Carbohydrate-electrolyte solutions

Carbohydrateelectrolyte solutions enhance the absorption of water during physical exercise

In order to bear the claim carbohydrate enhancement of water 2011;9(6):2211 -electrolyte solutions should contain 80 absorption during 350 kcal/L from carbohydrates, and at exercise least 75 % of the energy should be derived from carbohydrates which induce a high glycaemic response, such as glucose, glucose polymers and sucrose. In addition, these beverages should contain between 20 mmol/L (460 mg/L) and 50 mmol/L (1,150 mg/L) of sodium, and have an osmolality between 200 330 mOsm/kg water.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

314, 315, 316, 317, 319, 322, 325, 332, 408, 465, 473, 1168, 1574, 1593, 1618, 4302, 4309

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrates

Carbohydrates contribute to the maintenance of normal brain function

In order to bear the claim, information Maintenance of normal 2011;9(6):2226 shall be given to the consumer that the brain function beneficial effect is obtained with a daily intake of 130 g of carbohydrates from all sources. The claim may be used for food which contains at least 20 g carbohydrates which are metabolised by humans, excluding polyols, per quantified portion and complies with the nutrition claim LOW SUGARS or WITH NO ADDED SUGARS as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 1018/2013 of 23/10/2013

Authorised

603, 653

Art.13(1) Chitosan

The claim shall not be used on food which is 100% sugars. Chitosan contributes to The claim may be used only for food maintenance of normal 2011;9(6):2214 the maintenance of which provides a daily intake of 3 g of blood LDL-cholesterol normal blood chitosan. In order to bear the claim concentrations cholesterol levels information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of chitosan.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

4663

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is at least a source of chloride as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.The claim cannot be used on chloride from the source sodium chloride

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chloride

Chloride contributes to normal digestion by production of hydrochloric acid in the stomach

contribution to normal 2010;8(10):1764 digestion by production of hydrochloric acid in the stomach

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

326

Art.13(1) Choline

Choline contributes to normal homocysteine metabolism

The claim cannot be used on chloride from the source sodium chloride The claim may be used only for food Contribution to normal 2011;9(4):2056 which contains at least 82,5 mg of homocysteine choline per 100 g or 100 ml or per metabolism single portion of food.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

3090

Art.13(1) Choline

Choline contributes to The claim may be used only for food normal lipid metabolism which contains at least 82,5 mg of choline per 100 g or 100 ml or per single portion of food.

Contribution to normal 2011;9(4):2056 lipid metabolism

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

3186

Art.13(1) Choline

Choline contributes to the maintenance of normal liver function

The claim may be used only for food which contains at least 82,5 mg of choline per 100 g or 100 ml or per single portion of food.

Maintenance of normal 2011;9(4):2056, liver function 2011;9(6):2203

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

712, 1501, 1633

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chromium

Chromium contributes The claim may be used only for food contribution to normal to normal macronutrient which is at least a source of trivalent macronutrient metabolism chromium as referred to in the claim metabolism SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1732

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

260, 401, 4665, 4666, 4667

Art.13(1) Chromium

Chromium contributes to the maintenance of normal blood glucose levels

The claim may be used only for food maintenance of normal 2010;8(10):1732, which is at least a source of trivalent blood glucose 2011;9(6):2203 chromium as referred to in the claim concentrations SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

262, 4667, 4698

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hydroxypropyl methylcellulose (HPMC)

Consumption of Hydroxypropyl methylcellulose with a meal contributes to a reduction in the blood glucose rise after that meal

The claim may be used only for food reduction of postwhich contains 4 g of HPMC per prandial glycaemic quantified portion as part of the meal. responses In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained by consuming 4 g of HPMC as part of the meal.Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach.

2010;8(10):1739

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

814

Art.13(1) Alpha-cyclodextrin

Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Consumption of alpha- The claim may be used for food which Reduction of postcyclodextrin as part of a contains at least 5 g of alphaprandial glycaemic starch-containing meal cyclodextrin per 50 g of starch in a responses contributes to the quantified portion as part of the meal. reduction of the blood In order to bear the claim information glucose rise after that shall be given to the consumer that the meal beneficial effect is obtained by consuming the alpha-cyclodextrin as part of the meal.

2010;8(2):1479, 2012;10(6):2713

Commission Regulation (EU) 536/2013 of 11/06/2013

Authorised

2926

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Arabinoxylan produced from wheat endosperm

Consumption of arabinoxylan as part of a meal contributes to a reduction of the blood glucose rise after that meal

The claim may be used only for food reduction of postwhich contains at least 8 g of prandial glycaemic arabinoxylan (AX)-rich fibre produced responses from wheat endosperm (at least 60 % AX by weight) per 100 g of available carbohydrates in a quantified portion as part of the meal. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained by consuming the arabinoxylan (AX)-rich fibre produced from wheat endosperm as part of the meal.

2011;9(6):2205

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

830

Art.13(1) Beta-glucans from oats andConsumption of betabarley glucans from oats or barley as part of a meal contributes to the reduction of the blood glucose rise after that meal

The claim may be used only for food reduction of postwhich contains at least 4 g of betaprandial glycaemic glucans from oats or barley for each responses 30 g of available carbohydrates in a quantified portion as part of the meal. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained by consuming the beta-glucans from oats or barley as part of the meal.

2011;9(6):2207

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

821, 824

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructose

Consumption of foods containing fructose leads to a lower blood glucose rise compared to foods containing sucrose or glucose

In order to bear the claim, glucose Reduction of postand/or sucrose should be replaced by prandial glycaemic fructose in sugar-sweetened foods or responses drinks so that the reduction in content of glucose and/or sucrose, in these foods or drinks, is at least 30%.

2011;9(6):2223

Commission Regulation (EU) 536/2013 of 11/06/2013

Authorised

558

Art.13(1) Sugar replacers, i.e. intense sweeteners; xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, sucralose and polydextrose; D-tagatose and isomaltulose

Consumption of foods/drinks containing <name of sugar replacer> instead of sugar* contributes to the maintenance of tooth mineralisation

In order to bear the claim, sugars maintenance of tooth should be replaced in foods or drinks mineralisation by (which reduce plaque pH below 5.7) by decreasing tooth sugar replacers, i.e. intense demineralisation sweeteners, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, Dtagatose, isomaltulose, sucralose or polydextrose, or a combination of * In the case of Dthem, in amounts such that tagatose and consumption of such foods or drinks isomaltulose this should does not lower plaque pH below 5.7 read "other sugars" during and up to 30 minutes after consumption

2011;9(4):2076, 2011;9(6):2229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

463, 464, 563, 618, 647, 1134, 1167, 1182, 1283, 1591, 2907, 2921, 4300

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sugar replacers, i.e. intense sweeteners; xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, sucralose and polydextrose; D-tagatose and isomaltulose

Consumption of foods/drinks containing <name of sugar replacer> instead of sugar* induces a lower blood glucose rise after their consumption compared to sugarcontaining foods/drinks

* In the case of Dtagatose and isomaltulose this should read "other sugars" In the case of D-tagatose and isomaltulose, they should replace equivalent amounts of other sugars in the same proportion as that referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006.

In order to bear the claim, sugars reduction of postshould be replaced in foods or drinks prandial glycaemic by sugar replacers, i.e. intense responses sweeteners, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, sucralose or polydextrose, or a combination of them, so that foods or drinks contain reduced amounts of sugars by at least the amount referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006.

2011;9(4):2076, 2011;9(6):2229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

617, 619, 669, 1590, 1762, 2903, 2908, 2920, 4298

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pectins

Consumption of pectins with a meal contributes to the reduction of the blood glucose rise after that meal

The claim may be used only for food Reduction of postwhich contains 10 g of pectins per prandial glycaemic quantified portion. In order to bear the responses claim, information shall be given to the consumer that the beneficial effect is obtained by consuming 10 g of pectins as part of the meal.Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach.

2010;8(10):1747

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

786

Art.13(1) Copper

Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Copper contributes to The claim may be used only for food maintenance of maintenance of normal which is at least a source of copper as connective tissues connective tissues referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1211

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

265, 271, 1722

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Copper

Copper contributes to The claim may be used only for food Contribution to normal 2009;7(9):1211, normal energy-yielding which is at least a source of copper as energy-yielding 2011;9(4):2079 metabolism referred to in the claim SOURCE OF metabolism [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

266, 1729

Art.13(1) Copper

Copper contributes to normal functioning of the nervous system

The claim may be used only for food Maintenance of the which is at least a source of copper as normal function of the referred to in the claim SOURCE OF nervous system [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1211, 2011;9(4):2079

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

267, 1723

Art.13(1) Copper

Copper contributes to normal hair pigmentation

The claim may be used only for food maintenance of skin which is at least a source of copper as and hair pigmentation referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1211

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

268, 1724

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Copper

Copper contributes to The claim may be used only for food iron transport normal iron transport in which is at least a source of copper as the body referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1211

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

269, 270, 1727

Art.13(1) Copper

Copper contributes to normal skin pigmentation

The claim may be used only for food maintenance of skin which is at least a source of copper as and hair pigmentation referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1211

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

268, 1724

Art.13(1) Copper

Copper contributes to the normal function of the immune system

The claim may be used only for food Maintenance of the which is at least a source of copper as normal function of the referred to in the claim SOURCE OF immune system [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1211, 2011;9(4):2079

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

264, 1725

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Page 18

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Copper

Copper contributes to the protection of cells from oxidative stress

The claim may be used only for food protection of DNA, 2009;7(9):1211 which is at least a source of copper as proteins and lipids from referred to in the claim SOURCE OF oxidative damage [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

263, 1726

Art.13(1) Creatine

Creatine increases The claim may be used only for food physical performance in which provides a daily intake of 3 g of successive bursts of creatine. In order to bear the claim short-term, high information shall be given to the intensity exercise consumer that the beneficial effect is obtained with a daily intake of 3 g of creatine.The claim may be used only for foods targeting adults performing high intensity exercise The claim may be used only for foods targeting adults performing high intensity exercise

increase in physical performance during short-term, high intensity, repeated exercise bouts

2011;9(7):2303

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

739, 1520, 1521, 1522, 1523, 1525, 1526, 1531, 1532, 1533, 1534, 1922, 1923, 1924

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Page 19

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Docosahexaenoic acid and DHA and EPA Eicosapentaenoic acid contribute to the (DHA/EPA) maintenance of normal blood pressure

The claim may be used only for food Maintenance of normal 2009; 7(9); 1263, which provides a daily intake of 3 g of blood pressure 2010;8(10):1796 EPA and DHA. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of EPA and DHA. When the claim is used on food supplements and/or fortified foods information shall also be given to consumers not to exceed a supplemental daily intake of 5 g of EPA and DHA combined.

Commission Regulation (EU) 536/2013 of 11/06/2013

Authorised

502, 506, 516, 703, 1317, 1324

The claim shall not be used for foods targeting children. Art.13(1) Docosahexaenoic acid and DHA and EPA The claim may be used only for food Maintenance of normal 2009; 7(9); 1263, Eicosapentaenoic acid contribute to the which provides a daily intake of 2 g of (fasting) blood 2010;8(10):1796 (DHA/EPA) maintenance of normal EPA and DHA. In order to bear the concentrations of blood triglyceride levels claim, information shall be given to the triglycerides consumer that the beneficial effect is obtained with a daily intake of 2 g of EPA and DHA. When the claim is used on food supplements and/or fortified foods information shall also be given to consumers not to exceed a supplemental daily intake of 5 g of EPA and DHA combined. The claim shall not be used for foods targeting children.

Commission Regulation (EU) 536/2013 of 11/06/2013

Authorised

506, 517, 527, 538, 1317, 1324, 1325

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Page 20

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Docosahexaenoic acid (DHA)

DHA contributes to The claim may be used only for food maintenance of normal 2010;8(10):1734, maintenance of normal which contains at least 40 mg of DHA brain function 2011;9(4):2078 brain function per 100 g and per 100 kcal. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250 mg of DHA.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

497, 501, 510, 513, 519, 521, 534, 540, 688, 1323, 1360, 4294, 565, 626, 631, 689, 690, 704, 742, 3148, 3151

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Docosahexaenoic acid (DHA)

DHA contributes to the The claim may be used only for food maintenance of normal which provides a daily intake of 2 g of blood triglyceride levels DHA and which contains DHA in combination with eicosapentaenoic acid (EPA). In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 2 g of DHA. When the claim is used on food supplements and/or fortified foods information shall also be given to consumers not to exceed a supplemental daily intake of 5 g of EPA and DHA combined.

Maintenance of normal 2010;8(10):1734 (fasting) blood concentrations of triglycerides

Commission Regulation (EU) 536/2013 of 11/06/2013

Authorised

533, 691, 3150

Art.13(1) Docosahexaenoic acid (DHA)

The claim shall not be used for foods targeting children. DHA contributes to the The claim may be used only for food maintenance of normal 2010;8(10):1734, maintenance of normal which contains at least 40 mg of DHA vision 2011;9(4):2078 vision per 100 g and per 100 kcal. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250 mg of DHA.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

508, 510, 513, 519, 529, 540, 688, 2905, 4294, 627, 632, 743, 3149

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Page 22

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Dried plums of 'prune' Dried plums/prunes cultivars (Prunus domesticacontribute to normal L.) bowel function

The claim may be used only for food Maintenance of normal 2010;8(2):1486, which provides a daily intake of 100 g bowel function 2012;10(6):2712 of dried plums (prunes). In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 g of dried plums (prunes).

Commission Regulation (EU) 536/2013 of 11/06/2013

Authorised

1164

Art.13(1) Eicosapentaenoic acid and EPA and DHA The claim may be used only for food maintenance of normal 2010;8(10):1796, docosahexaenoic acid contribute to the normal which is at least a source of EPA and cardiac function 2011;9(4):2078 (EPA/DHA) function of the heart DHA as referred to in the claim SOURCE OF OMEGA 3 FATTY ACIDS as listed in the Annex to Regulation (EC) No 1924/2006. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250 mg of EPA and DHA.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

Art.13(1) Fluoride

Fluoride contributes to The claim may be used only for food maintenance of tooth the maintenance of which is at least a source of fluoride as mineralisation tooth mineralisation referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1212, 2010;8(10):1797

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

510, 688, 1360, 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325 275, 276, 338, 4238

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Page 23

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Folate

Folate contributes to The claim may be used only for food maternal tissue growth 2009;7(9):1213 maternal tissue growth which is at least a source of folate as during pregnancy during pregnancy referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

2882

Art.13(1) Folate

Folate contributes to normal amino acid synthesis

The claim may be used only for food contribution to normal which is at least a source of folate as amino acid synthesis referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1760

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

195, 2881

Art.13(1) Folate

Folate contributes to The claim may be used only for food blood formation normal blood formation which is at least a source of folate as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1213

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

79

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Page 24

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Folate

Folate contributes to normal homocysteine metabolism

The claim may be used only for food homocysteine which is at least a source of folate as metabolism referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1213

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

80

Art.13(1) Folate

Folate contributes to normal psychological function

The claim may be used only for food contribution to normal 2010;8(10):1760 which is at least a source of folate as psychological functions referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

81, 85, 86, 88

Art.13(1) Folate

Folate contributes to the The claim may be used only for food function of the immune 2009;7(9):1213 normal function of the which is at least a source of folate as system immune system referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

91

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Page 25

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Folate

Folate contributes to the The claim may be used only for food reduction of tiredness reduction of tiredness which is at least a source of folate as and fatigue and fatigue referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1760

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

84

Art.13(1) Folate

Folate has a role in the The claim may be used only for food cell division process of cell division which is at least a source of folate as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1213, 2010;8(10):1760

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

193, 195, 2881

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Page 26

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucomannan (konjac mannan)

Glucomannan contributes to the maintenance of normal blood cholesterol levels

The claim may be used only for food maintenance of normal 2009;7(9):1258, which provides a daily intake of 4 g of blood cholesterol 2010;8(10):1798 glucomannan. In order to bear the concentrations claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 4 g of glucomannan.Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

836, 1560, 3100, 3217

Generated on: 28/01/2014 09:37 AM

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucomannan (konjac mannan)

Glucomannan in the context of an energy restricted diet contributes to weight loss

The claim may be used only for food reduction of body which contains 1 g of glucomannan weight per quantified portion. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of glucomannan in three doses of 1 g each, together with 1-2 glasses of water, before meals and in the context of an energy-restricted diet. Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach.

2010;8(10):1798

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

854, 1556, 3725

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Guar Gum

Guar gum contributes to The claim may be used only for food Maintenance of normal 2010;8(2):1464 the maintenance of which provides a daily intake of 10 g of blood cholesterol normal blood guar gum. In order to bear the claim, concentrations cholesterol levels information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 10 g of guar gum.Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

808

Generated on: 28/01/2014 09:37 AM

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hydroxypropyl methylcellulose (HPMC)

Hydroxypropyl methylcellulose contributes to the maintenance of normal blood cholesterol levels

The claim may be used only for food maintenance of normal 2010;8(10):1739 which provides a daily intake of 5 g of blood cholesterol HPMC. In order to bear the claim concentrations information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 5 g of HPMC.Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. The claim may be used only for food contribution to normal which is at least a source of iodine as cognitive and referred to in the claim SOURCE OF neurological function [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

815

Art.13(1) Iodine

Iodine contributes to normal cognitive function

2010;8(10):1800

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

273

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Iodine

Iodine contributes to The claim may be used only for food contribution to normal normal energy-yielding which is at least a source of iodine as energy-yielding metabolism referred to in the claim SOURCE OF metabolism [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1214, 2010;8(10):1800

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

274, 402

Art.13(1) Iodine

Iodine contributes to normal functioning of the nervous system

The claim may be used only for food contribution to normal which is at least a source of iodine as cognitive and referred to in the claim SOURCE OF neurological function [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1800

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

273

Art.13(1) Iodine

Iodine contributes to the The claim may be used only for food maintenance of skin maintenance of normal which is at least a source of iodine as skin referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1214

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

370

Generated on: 28/01/2014 09:37 AM

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Iodine

Iodine contributes to the The claim may be used only for food normal production of which is at least a source of iodine as thyroid hormones and referred to in the claim SOURCE OF normal thyroid function [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

contribution to normal thyroid function and production of thyroid hormones

2009;7(9):1214, 2010;8(10):1800

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

274, 1237

Art.13(1) Iron

Iron contributes to normal cognitive function

The claim may be used only for food which is at least a source of iron as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

cognitive function

2009;7(9):1215

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

253

Art.13(1) Iron

Iron contributes to The claim may be used only for food normal energy-yielding which is at least a source of iron as metabolism referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

contribution to normal energy-yielding metabolism

2009;7(9):1215, 2010;8(10):1740

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

251, 255, 1589

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is at least a source of iron as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Iron

Iron contributes to normal formation of red blood cells and haemoglobin

formation of red blood 2009;7(9):1215, cells and haemoglobin 2010;8(10):1740

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

249, 374, 1589, 2889

Art.13(1) Iron

Iron contributes to The claim may be used only for food normal oxygen transport which is at least a source of iron as in the body referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

oxygen transport

2009;7(9):1215, 2010;8(10):1740

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

250, 254, 255, 256

Art.13(1) Iron

Iron contributes to the normal function of the immune system

The claim may be used only for food which is at least a source of iron as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

function of the immune 2009;7(9):1215 system

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

252, 259

Generated on: 28/01/2014 09:37 AM

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is at least a source of iron as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Iron

Iron contributes to the reduction of tiredness and fatigue

reduction of tiredness and fatigue

2010;8(10):1740

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

255, 374, 2889

Art.13(1) Iron

Iron has a role in the The claim may be used only for food process of cell division which is at least a source of iron as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

cell division

2009;7(9):1215

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

368

Generated on: 28/01/2014 09:37 AM

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820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactase enzyme

Lactase enzyme improves lactose digestion in individuals who have difficulty digesting lactose

The claim may be used only for food breaking down lactose 2009;7(9):1236, supplements, with a minimum dose of 2011;9(6):2203 4500 FCC (Food Chemicals Codex) units with instructions to the target population to consume with each lactose containing meal.Information shall also be given to the target population that tolerance to lactose is variable and they should seek advice as to the role of this substance in their diet.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1697, 1818, 1974

Art.13(1) Lactulose

Information shall also be given to the target population that tolerance to lactose is variable and they should seek advice as to the role of this substance in their diet. Lactulose contributes to The claim may be used only for food reduction in intestinal an acceleration of which contains 10 g of lactulose in a transit time intestinal transit single quantified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a single serving of 10 g of lactulose per day.

2010;8(10):1806

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

807

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Linoleic acid

Linoleic acid contributes The claim may be used only for a food maintenance of normal 2009;7(9):1276, to the maintenance of which provides at least 1,5 g of linoleic blood cholesterol 2011;9(6):2235 normal blood acid (LA) per 100 g and per 100 kcal. concentrations cholesterol levels Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 10 g of LA.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

489, 2899

Art.13(1) Live yoghurt cultures

Live cultures in yoghurt or fermented milk improve lactose digestion of the product in individuals who have difficulty digesting lactose

In order to bear the claim, yoghurt or improved lactose fermented milk should contain at least digestion 108 Colony Forming Units live starter microorganisms (Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus) per gram.

2010;8(10):1763

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1143, 2976

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food Reduction of tiredness 2010;8(10):1807 to a reduction of which is at least a source of and fatigue tiredness and fatigue magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

244

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food electrolyte balance to electrolyte balance which is at least a source of magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1216

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

238

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food energy-yielding to normal energywhich is at least a source of metabolism yielding metabolism magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1216

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

240, 247, 248

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food neurotransmission and 2009;7(9):1216 to normal functioning of which is at least a source of muscle contraction the nervous system magnesium as referred to in the claim including heart muscle SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

242

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food neurotransmission and 2009;7(9):1216, to normal muscle which is at least a source of muscle contraction 2010;8(10):1807 function magnesium as referred to in the claim including heart muscle SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

241, 380, 3083

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food protein synthesis to normal protein which is at least a source of synthesis magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1216

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

364

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food Contribution to normal 2010;8(10):1807 to normal psychological which is at least a source of psychological functions function magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

245, 246

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food maintenance of bones 2009;7(9):1216 to the maintenance of which is at least a source of normal bones magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

239

Art.13(1) Magnesium

Magnesium contributes The claim may be used only for food maintenance of teeth to the maintenance of which is at least a source of normal teeth magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1216

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

239

Art.13(1) Magnesium

Magnesium has a role The claim may be used only for food cell division in the process of cell which is at least a source of division magnesium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006

2009;7(9):1216

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

365

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Manganese

Manganese contributes The claim may be used only for food contribution to normal to normal energywhich is at least a source of energy-yielding yielding metabolism manganese as referred to in the claim metabolism SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1217, 2010;8(10):1808

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

311, 405

Art.13(1) Manganese

Manganese contributes The claim may be used only for food maintenance of bones 2009;7(9):1217 to the maintenance of which is at least a source of normal bones manganese as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

310

Art.13(1) Manganese

Manganese contributes The claim may be used only for food contribution to normal 2010;8(10):1808 to the normal formation which is at least a source of formation of connective of connective tissue manganese as referred to in the claim tissue SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

404

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Manganese

Manganese contributes The claim may be used only for food metabolism of fatty to the protection of cells which is at least a source of acids from oxidative stress manganese as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1217

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

309

Art.13(1) Meat or fish

Meat or fish contributes to the improvement of iron absorption when eaten with other foods containing iron

The claim may be used only for food improvement of nonwhich contains at least 50 g of meat or haem iron absorption fish in a single quantified portion. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained by consuming 50 g of meat or fish together with food(s) containing nonhaem iron.

2011;9(4):2040

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1223

Art.13(1) Melatonin

Melatonin contributes to The claim may be used only for food Alleviation of subjective 2010;8(2):1467 the alleviation of which contains at least 0,5 mg of feelings of jet lag subjective feelings of jet melatonin per quantified portion. In lag order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a minimum intake of 0,5 mg to be taken close to bedtime on the first day of travel and on the following few days after arrival at the destination.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1953

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Melatonin

Melatonin contributes to The claim may be used only for food reduction of sleep onset 2011;9(6):2241 the reduction of time which contains 1 mg of melatonin per latency taken to fall asleep quantified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained by consuming 1 mg of melatonin close to bedtime.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1698, 1780, 4080

Art.13(1) Molybdenum

Molybdenum contributes to normal sulphur amino acid metabolism

The claim may be used only for food contribution to normal 2010;8(10):1745 which is at least a source of amino acid metabolism molybdenum as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

313

Art.13(1) Monascus purpureous (red Monacolin K from red The claim may be used only for food maintenance of normal 2011;9(7):2304 yeast rice) yeast rice contributes to which provides a daily intake of 10 mg blood LDL-cholesterol the maintenance of of monacolin K from red yeast rice. In concentrations normal blood order to bear the claim, information cholesterol levels shall be given to the consumer that the beneficial effect is obtained with a daily intake of 10 mg of monacolin K from fermented red yeast rice preparations.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1648, 1700

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Niacin

Niacin contributes to The claim may be used only for food contribution to normal normal energy-yielding which is at least a source of niacin as energy-yielding metabolism referred to in the claim SOURCE OF metabolism [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1224, 2010;8(10):1757

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

43, 49, 51, 54

Art.13(1) Niacin

Niacin contributes to normal functioning of the nervous system

The claim may be used only for food function of the nervous 2009;7(9):1224 which is at least a source of niacin as system referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

44, 53

Art.13(1) Niacin

Niacin contributes to normal psychological function

The claim may be used only for food contribution to normal 2010;8(10):1757 which is at least a source of niacin as psychological functions referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

55

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Niacin

Niacin contributes to the The claim may be used only for food maintenance of normal 2009;7(9):1224, maintenance of normal which is at least a source of niacin as skin and mucous 2010;8(10):1757 mucous membranes referred to in the claim SOURCE OF membranes [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

45, 52, 4700

Art.13(1) Niacin

Niacin contributes to the The claim may be used only for food maintenance of normal 2009;7(9):1224, maintenance of normal which is at least a source of niacin as skin and mucous 2010;8(10):1757 skin referred to in the claim SOURCE OF membranes [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

45, 48, 50, 52, 4700

Art.13(1) Niacin

Niacin contributes to the The claim may be used only for food reduction of tiredness reduction of tiredness which is at least a source of niacin as and fatigue and fatigue referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1757

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

47

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Oat grain fibre

Oat grain fibre The claim may be used only for food increase in faecal bulk 2011;9(6):2249 contributes to an which is high in that fibre as referred to increase in faecal bulk in the claim HIGH FIBRE as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

822

Art.13(1) Olive oil polyphenols

Olive oil polyphenols The claim may be used only for olive protection of LDL 2011;9(4):2033 contribute to the oil which contains at least 5 mg of particles from oxidative protection of blood lipids hydroxytyrosol and its derivatives (e.g. damage from oxidative stress oleuropein complex and tyrosol) per 20 g of olive oil. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 20 g of olive oil.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1333, 1638, 1639, 1696, 2865

Art.13(1) Pantothenic acid

Pantothenic acid contributes to normal energy-yielding metabolism

The claim may be used only for food energy-yielding which is at least a source of metabolism pantothenic acid as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1218

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

56, 59, 60, 64, 171, 172, 208

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pantothenic acid

Pantothenic acid contributes to normal mental performance

The claim may be used only for food mental performance which is at least a source of pantothenic acid as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1218, 2010;8(10):1758

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

57, 58

Art.13(1) Pantothenic acid

Pantothenic acid contributes to normal synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters

The claim may be used only for food which is at least a source of pantothenic acid as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters

2009;7(9):1218

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

181

Art.13(1) Pantothenic acid

Pantothenic acid contributes to the reduction of tiredness and fatigue

The claim may be used only for food reduction of tiredness which is at least a source of and fatigue pantothenic acid as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1758

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

63

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pectins

Pectins contribute to the The claim may be used only for food maintenance of normal 2010;8(10):1747, maintenance of normal which provides a daily intake of 6 g of blood cholesterol 2011;9(6):2203 blood cholesterol levels pectins. In order to bear the claim concentrations information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 6 g of pectins.Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Warning of choking to be given for people with swallowing difficulties or when ingesting with inadequate fluid intake - advice on taking with plenty of water to ensure substance reaches stomach. Phosphorus contributes The claim may be used only for food energy-yielding to normal energywhich is at least a source of metabolism yielding metabolism phosphorus as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

818, 4236

Art.13(1) Phosphorus

2009;7(9):1219

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

329, 373

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Phosphorus

Phosphorus contributes The claim may be used only for food function of cell to normal function of which is at least a source of membranes cell membranes phosphorus as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1219

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

328

Art.13(1) Phosphorus

Phosphorus contributes The claim may be used only for food maintenance of bone to the maintenance of which is at least a source of and teeth normal bones phosphorus as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1219

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

324, 327

Art.13(1) Phosphorus

Phosphorus contributes The claim may be used only for food maintenance of bone to the maintenance of which is at least a source of and teeth normal teeth phosphorus as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1219

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

324, 327

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Plant sterols and plant stanols

Plant sterols/stanols contribute to the maintenance of normal blood cholesterol levels

In order to bear the claim information maintenance of normal 2010;8(10):1813, shall be given to the consumer that the blood cholesterol 2011;9(6):2203 beneficial effect is obtained with a daily concentrations intake of at least 0.8 g of plant sterols/stanols.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

Art.13(1) Potassium

Potassium contributes The claim may be used only for food Muscular and to normal functioning of which is at least a source of potassium neurological function the nervous system as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(2):1469

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

549, 550, 567, 568, 713, 1234, 1235, 1466, 1634, 1984, 2909, 3140 386

Art.13(1) Potassium

Potassium contributes The claim may be used only for food Muscular and to normal muscle which is at least a source of potassium neurological function function as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(2):1469

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

320

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Potassium

Potassium contributes The claim may be used only for food Blood pressure to the maintenance of which is at least a source of potassium normal blood pressure as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(2):1469

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

321

Art.13(1) Protein

Protein contributes to a The claim may be used only for food growth or maintenance 2010;8(10):1811, growth in muscle mass which is at least a source of protein as of muscle mass 2011;9(6):2203 referred to in the claim SOURCE OF PROTEIN as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

Art.13(1) Protein

Protein contributes to the maintenance of muscle mass

The claim may be used only for food growth or maintenance 2010;8(10):1811, which is at least a source of protein as of muscle mass 2011;9(6):2203 referred to in the claim SOURCE OF PROTEIN as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

Art.13(1) Protein

Protein contributes to the maintenance of normal bones

The claim may be used only for food maintenance of normal 2010;8(10):1811, which is at least a source of protein as bones 2011;9(6):2203 referred to in the claim SOURCE OF PROTEIN as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

415, 417, 593, 594, 595, 715, 1398 415, 417, 593, 594, 595, 715, 1398 416, 4704

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Foods with a low or reduced content of saturated fatty acids

Reducing consumption of saturated fat contributes to the maintenance of normal blood cholesterol levels

The claim may be used only for food maintenance of normal 2011;9(4):2062 which is at least low in saturated fatty blood LDL-cholesterol acids, as referred to in the claim LOW concentrations SATURATED FAT or reduced in saturated fatty acids as referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

620, 671, 4332

Art.13(1) Foods with a low or Reducing consumption The claim may be used only for food maintenance of normal 2011;9(6):2237 reduced content of sodium of sodium contributes to which is at least low in sodium/salt as blood pressure the maintenance of referred to in the claim LOW normal blood pressure SODIUM/SALT or reduced in sodium/salt as referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

336, 705, 1148, 1178, 1185, 1420

Art.13(1) Resistant starch

Replacing digestible starches with resistant starch in a meal contributes to a reduction in the blood glucose rise after that meal.

The claim may be used only for food in reduction of postwhich digestible starch has been prandial glycaemic replaced by resistant starch so that the responses final content of resistant starch is at least 14 % of total starch.

2011;9(4):2024

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

681

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Oleic acid

Replacing saturated fats The claim may be used only for food in the diet with which is high in unsaturated fatty unsaturated fats acids, as referred to in the claim HIGH contributes to the UNSATURATED FAT as listed in the maintenance of normal Annex to Regulation (EC) No blood cholesterol levels. 1924/2006. Oleic acid is an unsaturated fat. Art.13(1) Monounsaturated and/or Replacing saturated fats The claim may be used only for food polyunsaturated fatty acids with unsaturated fats in which is high in unsaturated fatty the diet contributes to acids, as referred to in the claim HIGH the maintenance of UNSATURATED FAT as listed in the normal blood Annex to Regulation (EC) No cholesterol levels 1924/2006. [MUFA and PUFA are unsaturated fats]

maintenance of normal 2011;9(4):2043 blood LDL-cholesterol concentrations

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

673, 728, 729, 1302, 4334

Art.13(1) Riboflavin (Vitamin B2)

Replacement of 2011;9(4):2069, mixtures of saturated 2011;9(6):2203 fatty acids (SFAs) as present in foods or diets with mixtures of polyunsaturated fatty acids (PUFAs) and maintenance of normal blood LDL-cholesterol concentrations Riboflavin contributes to The claim may be used only for food contribution to normal 2010;8(10):1814 normal energy-yielding which is at least a source of riboflavin energy-yielding metabolism as referred to in the claim SOURCE metabolism OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

621, 674, 1190, 1203, 2906, 2910, 3065, 4335

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

29, 35, 36, 42

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food maintenance of the normal functioning of which is at least a source of riboflavin normal functon of the the nervous system as referred to in the claim SOURCE nervous system OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1814

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

213

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food maintenance of normal 2010;8(10):1814 the maintenance of which is at least a source of riboflavin skin and mucous normal mucous as referred to in the claim SOURCE membranes membranes OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

31

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food maintenance of normal 2010;8(10):1814 the maintenance of which is at least a source of riboflavin red blood cells normal red blood cells as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

40

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food maintenance of normal 2010;8(10):1814 the maintenance of which is at least a source of riboflavin skin and mucous normal skin as referred to in the claim SOURCE membranes OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

31, 33

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food maintenance of normal 2010;8(10):1814 the maintenance of which is at least a source of riboflavin vision normal vision as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

39

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food contribution to normal the normal metabolism which is at least a source of riboflavin metabolism of iron of iron as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1814

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

30, 37

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food protection of DNA, 2010;8(10):1814 the protection of cells which is at least a source of riboflavin proteins and lipids from from oxidative stress as referred to in the claim SOURCE oxidative damage OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

207

Art.13(1) Riboflavin (Vitamin B2)

Riboflavin contributes to The claim may be used only for food reduction of tiredness the reduction of which is at least a source of riboflavin and fatigue tiredness and fatigue as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1814

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

41

Art.13(1) Rye fibre

Rye fibre contributes to The claim may be used only for food changes in bowel normal bowel function which is high in that fibre as referred to function in the claim HIGH FIBRE as listed in the Annex to Regulation (EC) No 1924/2006.

2011;9(6):2258

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

825

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Selenium

Selenium contributes to The claim may be used only for food spermatogenesis normal which is at least a source of selenium spermatogenesis as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1220

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

396

Art.13(1) Selenium

Selenium contributes to The claim may be used only for food maintenance of normal 2010;8(10):1727 the maintenance of which is at least a source of selenium hair normal hair as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

281

Art.13(1) Selenium

Selenium contributes to The claim may be used only for food maintenance of normal 2010;8(10):1727 the maintenance of which is at least a source of selenium nails normal nails as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

281

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Selenium

Selenium contributes to The claim may be used only for food maintenance of the the normal function of which is at least a source of selenium normal function of the the immune system as referred to in the claim SOURCE immune system OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1220, 2010;8(10):1727

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

278, 1750

Art.13(1) Selenium

Selenium contributes to The claim may be used only for food thyroid function the normal thyroid which is at least a source of selenium function as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1220, 2010;8(10):1727

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

Art.13(1) Selenium

Selenium contributes to The claim may be used only for food protection of DNA, 2009;7(9):1220, the protection of cells which is at least a source of selenium proteins and lipids from 2010;8(10):1727 from oxidative stress as referred to in the claim SOURCE oxidative damage OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

279, 282, 286, 410, 1289, 1290, 1291, 1292, 1293 277, 283, 286, 410, 1289, 1290, 1291, 1292, 1293, 1751

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Meal replacement for weight control

Substituting one daily meal of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss

In order to bear the claim, a food Maintenance of body 2010;8(2):1466 should comply with specifications laid weight after weight loss down in Directive 96/8/EC in relation to food products under Article 1(2)(b) of that Directive. In order to achieve the claimed effect, one meal should be substituted with meal replacements daily.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1418

Art.13(1) Meal replacement for weight control

Substituting two daily meals of an energy restricted diet with meal replacements contributes to weight loss

In order to bear the claim, a food Reduction in body should comply with specifications laid weight down in Directive 96/8/EC in relation to food products under Article 1(2)(b) of that Directive. In order to achieve the claimed effect, two meals should be substituted with meal replacements daily.

2010;8(2):1466

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1417

Art.13(1) Sugar-free chewing gum

Sugar-free chewing gum contributes to the maintenance of tooth mineralization

The claim may be used only for maintenance of tooth chewing gum which complies with the mineralisation conditions of use for the nutrition claim SUGARS FREE as listed in the Annex to Regulation (EC) No 1924/2006. Information shall be given to the consumer that the beneficial effect is obtained with chewing, for at least 20 minutes, after eating or drinking.

2009;7(9):1271, 2011;9(4):2072, 2011;9(6):2266

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

486, 562, 1151, 1154, 1181

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sugar-free chewing gum

Sugar-free chewing gum contributes to the neutralisation of plaque acids

The claim may be used only for plaque acid chewing gum which complies with the neutralisation conditions of use for the nutrition claim SUGARS FREE as listed in the Annex to Regulation (EC) No 1924/2006. Information shall be given to the consumer that the beneficial effect is obtained with chewing, for at least 20 minutes, after eating or drinking.

2009;7(9):1271, 2011;9(6):2266

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

485, 1150

Art.13(1) Sugar-free chewing gum

Sugar-free chewing gum contributes to the reduction of oral dryness

The claim may be used only for reduction of oral chewing gum which complies with the dryness conditions of use for the nutrition claim SUGARS FREE as listed in the Annex to Regulation (EC) No 1924/2006. Information shall be given to the consumer that the beneficial effect is obtained with use of the chewing gum whenever the mouth feels dry

2009;7(9):1271

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1240

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sugar-free chewing gum with carbamide

Sugar-free chewing The claim may be used only for plaque acid gum with carbamide chewing gum which complies with the neutralisation neutralises plaque acids conditions of use for the nutrition claim more effectively than SUGARS FREE as listed in the Annex sugar-free chewing to Regulation (EC) No 1924/2006. gums without In order to bear the claim each piece carbamide of sugar-free chewing gum should contain at least 20 mg carbamide. Information shall be given to the consumer that gum should be chewed for at least 20 minutes after eating or drinking.

2011;9(4):2071

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1153

Art.13(1) Thiamine

Thiamine contributes to The claim may be used only for food energy-yielding normal energy-yielding which is at least a source of thiamine metabolism metabolism as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1222

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

21, 24, 28

Art.13(1) Thiamine

Thiamine contributes to The claim may be used only for food function of the nervous 2009;7(9):1222 normal functioning of which is at least a source of thiamine system the nervous system as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

22, 27

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Thiamine

Thiamine contributes to The claim may be used only for food contribution to normal 2010;8(10):1755 normal psychological which is at least a source of thiamine psychological functions function as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

205

Art.13(1) Thiamine

Thiamine contributes to The claim may be used only for food cardiac function the normal function of which is at least a source of thiamine the heart as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1222

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

20

Art.13(1) Vitamin A

Vitamin A contributes to The claim may be used only for food metabolism of iron normal iron metabolism which is at least a source of vitamin A as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1221

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

206

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin A

Vitamin A contributes to The claim may be used only for food maintenance of normal 2009;7(9):1221, the maintenance of which is at least a source of vitamin A skin and mucous 2010;8(10):1754 normal mucous as referred to in the claim SOURCE membranes membranes OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

15, 4702

Art.13(1) Vitamin A

Vitamin A contributes to The claim may be used only for food maintenance of normal 2009;7(9):1221, the maintenance of which is at least a source of vitamin A skin and mucous 2010;8(10):1754 normal skin as referred to in the claim SOURCE membranes OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

15, 17, 4660, 4702

Art.13(1) Vitamin A

Vitamin A contributes to The claim may be used only for food maintenance of normal 2009;7(9):1221, the maintenance of which is at least a source of vitamin A vision 2010;8(10):1754 normal vision as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

16, 4239, 4701

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin A

Vitamin A contributes to The claim may be used only for food maintenance of the the normal function of which is at least a source of vitamin A normal function of the the immune system as referred to in the claim SOURCE immune system OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1222, 2011;9(4):2021

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

14, 200, 1462

Art.13(1) Vitamin A

Vitamin A has a role in The claim may be used only for food cell differentiation the process of cell which is at least a source of vitamin A specialisation as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1221

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

14

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food energy-yielding to normal energywhich is at least a source of vitamin metabolism yielding metabolism B12 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1223

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

99, 190

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food contribution to 2010;8(10):4114 to normal functioning of which is at least a source of vitamin neurological and the nervous system B12 as referred to in the claim psychological function SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

95, 97, 98, 100, 102, 109

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food contribution to normal to normal homocysteine which is at least a source of vitamin homocysteine metabolism B12 as referred to in the claim metabolism SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):4114

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

96, 103, 106

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food contribution to 2010;8(10):4114 to normal psychological which is at least a source of vitamin neurological and function B12 as referred to in the claim psychological function SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

95, 97, 98, 100, 102, 109

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food red blood cell formation 2009;7(9):1223 to normal red blood cell which is at least a source of vitamin formation B12 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

92, 101

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food function of the immune 2009;7(9):1223 to the normal function of which is at least a source of vitamin system the immune system B12 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

107

Art.13(1) Vitamin B12

Vitamin B12 contributes The claim may be used only for food reduction of tiredness to the reduction of which is at least a source of vitamin and fatigue tiredness and fatigue B12 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):4114

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

108

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B12

Vitamin B12 has a role The claim may be used only for food cell division in the process of cell which is at least a source of vitamin division B12 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1223, 2010;8(10):1756

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

93, 212

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food contribution to normal to normal cysteine which is at least a source of vitamin B6 cysteine synthesis synthesis as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1759

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

4283

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food contribution to normal to normal energywhich is at least a source of vitamin B6 energy-yielding yielding metabolism as referred to in the claim SOURCE metabolism OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1759

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

75, 214

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food function of the nervous 2009;7(9):1225 to normal functioning of which is at least a source of vitamin B6 system the nervous system as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

66

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food contribution to normal to normal homocysteine which is at least a source of vitamin B6 homocysteine metabolism as referred to in the claim SOURCE metabolism OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1759

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

73, 76, 199

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food protein and glycogen to normal protein and which is at least a source of vitamin B6 metabolism glycogen metabolism as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1225

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

65, 70, 71

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food contribution to normal 2010;8(10):1759 to normal psychological which is at least a source of vitamin B6 psychological functions function as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

77

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food red blood cell formation 2009;7(9):1225 to normal red blood cell which is at least a source of vitamin B6 formation as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

67, 72, 186

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food function of the immune 2009;7(9):1225 to the normal function of which is at least a source of vitamin B6 system the immune system as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

68

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food reduction of tiredness to the reduction of which is at least a source of vitamin B6 and fatigue tiredness and fatigue as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1759

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

78

Art.13(1) Vitamin B6

Vitamin B6 contributes The claim may be used only for food regulation of hormonal 2009;7(9):1225 to the regulation of which is at least a source of vitamin B6 activity hormonal activity as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

69

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food maintain the normal which provides a daily intake of 200 function of the immune mg vitamin C. In order to bear the system during and after claim information shall be given to the intense physical consumer that the beneficial effect is exercise obtained with a daily intake of 200 mg in addition to the recommended daily intake of vitamin C.

function of the immune 2009;7(9):1226 system during and after extreme physical exercise

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

144

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food collagen formation normal collagen which is at least a source of vitamin C formation for the normal as referred to in the claim SOURCE function of blood OF [NAME OF VITAMIN/S] AND/OR vessels [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

130, 131, 149

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food collagen formation normal collagen which is at least a source of vitamin C formation for the normal as referred to in the claim SOURCE function of bones OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

131, 149

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food collagen formation normal collagen which is at least a source of vitamin C formation for the normal as referred to in the claim SOURCE function of cartilage OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

131, 149

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food collagen formation normal collagen which is at least a source of vitamin C formation for the normal as referred to in the claim SOURCE function of gums OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

131, 136, 149

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food collagen formation normal collagen which is at least a source of vitamin C formation for the normal as referred to in the claim SOURCE function of skin OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

131, 137, 149

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food collagen formation normal collagen which is at least a source of vitamin C formation for the normal as referred to in the claim SOURCE function of teeth OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

131, 149

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food contribution to normal normal energy-yielding which is at least a source of vitamin C energy-yielding metabolism as referred to in the claim SOURCE metabolism OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226, 2010;8(10):1815

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

135, 2334, 3196

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food function of the nervous 2009;7(9):1226 normal functioning of which is at least a source of vitamin C system the nervous system as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

133

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food contribution to normal 2010;8(10):1815 normal psychological which is at least a source of vitamin C psychological functions function as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

140

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food maintenance of the the normal function of which is at least a source of vitamin C normal function of the the immune system as referred to in the claim SOURCE immune system OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226, 2010;8(10):1815

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

134, 4321

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food protection of DNA, 2009;7(9):1226, the protection of cells which is at least a source of vitamin C proteins and lipids from 2010;8(10):1815 from oxidative stress as referred to in the claim SOURCE oxidative damage OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

129, 138, 143, 148, 3331

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food reduction of tiredness the reduction of which is at least a source of vitamin C and fatigue tiredness and fatigue as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2010;8(10):1815

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

139, 2622

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin C

Vitamin C contributes to The claim may be used only for food regeneration of the 2010;8(10):1815 the regeneration of the which is at least a source of vitamin C reduced form of vitamin reduced form of vitamin as referred to in the claim SOURCE E E OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

202

Art.13(1) Vitamin C

Vitamin C increases iron absorption

The claim may be used only for food non-haem iron which is at least a source of vitamin C absorption as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1226

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

132, 147

Art.13(1) Vitamin D

Vitamin D contributes to The claim may be used only for food normal which is at least a source of vitamin D absorption/utilisation of as referred to in the claim SOURCE calcium and OF [NAME OF VITAMIN/S] AND/OR phosphorus [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

absorption and 2009;7(9):1227, utilisation of calcium 2011;9(6):2203 and phosphorus and maintenance of normal blood calcium concentrations

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

152, 157, 215

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin D

Vitamin D contributes to The claim may be used only for food normal blood calcium which is at least a source of vitamin D levels as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

absorption and 2009;7(9):1227, utilisation of calcium 2011;9(6):2203 and phosphorus and maintenance of normal blood calcium concentrations

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

152, 157, 215

Art.13(1) Vitamin D

Vitamin D contributes to The claim may be used only for food maintenance of bones 2009;7(9):1227, the maintenance of which is at least a source of vitamin D and teeth 2009;7(9):1272 normal bones as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

150, 151, 158, 350

Art.13(1) Vitamin D

Vitamin D contributes to The claim may be used only for food Normal muscle function 2010;8(2):1468 the maintenance of which is at least a source of vitamin D normal muscle function as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

155

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin D

Vitamin D contributes to The claim may be used only for food maintenance of bones 2009;7(9):1227 the maintenance of which is at least a source of vitamin D and teeth normal teeth as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

151, 158

Art.13(1) Vitamin D

Vitamin D contributes to The claim may be used only for food Normal function of 2010;8(2):1468 the normal function of which is at least a source of vitamin D immune system and the immune system as referred to in the claim SOURCE inflammation response OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

154, 159

Art.13(1) Vitamin D

Vitamin D has a role in The claim may be used only for food cell division the process of cell which is at least a source of vitamin D division as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1227

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

153

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin E

Vitamin E contributes to The claim may be used only for food protection of DNA, 2010;8(10):1816 the protection of cells which is at least a source of vitamin E proteins and lipids from from oxidative stress as referred to in the claim SOURCE oxidative damage OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

160, 162, 1947

Art.13(1) Vitamin K

Vitamin K contributes to The claim may be used only for food blood coagulation normal blood clotting which is at least a source of vitamin K as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

2009;7(9):1228

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

124, 126

Art.13(1) Vitamin K

Vitamin K contributes to The claim may be used only for food maintenance of bones 2009;7(9):1228 the maintenance of which is at least a source of vitamin K normal bones as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

123, 127, 128, 2879

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Walnuts

Walnuts contribute to the improvement of the elasticity of blood vessels

The claim may be used only for food Improvement of 2011;9(4):2074 which provides a daily intake of 30 g of endothelium-dependent walnuts. In order to bear the claim, vasodilation information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 30 g of walnuts.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1155, 1157

Art.13(1) Water

Water contributes to the In order to bear the claim, information maintenance of normal 2011;9(4):2075 maintenance of normal shall be given to the consumer that in physical and cognitive physical and cognitive order to obtain the claimed effect, at functions functions least 2,0 L of water, from all sources, should be consumed per day.The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1102, 1209, 1294, 1331

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Water

Water contributes to the In order to bear the claim, information maintenance of normal 2011;9(4):2075 maintenance of normal shall be given to the consumer that in thermoregulation regulation of the body's order to obtain the claimed effect, at temperature least 2,0 L of water, from all sources, should be consumed per day.The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC The claim may be used only on water complying with Directives 2009/54/EC and/or 98/83/EC Wheat bran fibre The claim may be used only for food reduction in intestinal contributes to an which is high in that fibre as referred to transit time acceleration of intestinal in the claim HIGH FIBRE as listed in transit the Annex to Regulation (EC) No 1924/2006. In order to bear the claim information shall be given to the consumer that the claimed effect is obtained with a daily intake of at least 10 g of wheat bran fibre.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

1208

Art.13(1) Wheat bran fibre

2010;8(10):1817

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

828, 839, 3067, 4699

Art.13(1) Wheat bran fibre

Wheat bran fibre The claim may be used only for food Increase in faecal bulk 2010;8(10):1817 contributes to an which is high in that fibre as referred to increase in faecal bulk in the claim HIGH FIBRE as listed in the Annex to Regulation (EC) No 1924/2006.

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

3066

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Zinc contributes to The claim may be used only for food normal DNA synthesis which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

DNA synthesis and cell 2009;7(9):1229, division 2010;8(10):1819

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

292, 293, 1759

Art.13(1) Zinc

Zinc contributes to normal acid-base metabolism

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

acid-base metabolism 2009;7(9):1229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

360

Art.13(1) Zinc

Zinc contributes to normal carbohydrate metabolism

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

contribution to normal carbohydrate metabolism

2010;8(10):1819

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

382

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Zinc contributes to normal cognitive function

cognitive function

2009;7(9):1229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

296

Art.13(1) Zinc

Zinc contributes to normal fertility and reproduction

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

fertility and reproduction

2009;7(9):1229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

297, 300

Art.13(1) Zinc

Zinc contributes to normal macronutrient metabolism

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

contribution to normal macronutrient metabolism

2010;8(10):1819

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

2890

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Zinc contributes to normal metabolism of fatty acids

maintenance of normal 2009;7(9):1229 serum testosterone concentrations

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

302

Art.13(1) Zinc

Zinc contributes to normal metabolism of vitamin A

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

vitamin A metabolism

2009;7(9):1229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

361

Art.13(1) Zinc

Zinc contributes to normal protein synthesis

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

contribution to normal protein synthesis

2010;8(10):1819

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

293, 4293

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food maintenance of normal which is at least a source of zinc as bones referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of bones 2009;7(9):1229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

295, 1756

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food maintenance of normal which is at least a source of zinc as hair referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of normal 2010;8(10):1819 hair

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

412

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food maintenance of normal which is at least a source of zinc as nails referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of normal 2010;8(10):1819 nails

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

412

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food maintenance of normal which is at least a source of zinc as skin referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of normal 2010;8(10):1819 skin

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

293

Art.13(1) Zinc

Zinc contributes to the maintenance of normal testosterone levels in the blood

The claim may be used only for food which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

fertility and reproduction

2010;8(10):1819

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

301

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food maintenance of normal which is at least a source of zinc as vision referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

maintenance of vision 2009;7(9):1229

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

361

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food normal function of the which is at least a source of zinc as immune system referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

function of the immune 2009;7(9):1229 system

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

291, 1757

Art.13(1) Zinc

Zinc contributes to the The claim may be used only for food protection of cells from which is at least a source of zinc as oxidative stress referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

protection of DNA, 2009;7(9):1229 proteins and lipids from oxidative damage

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

294, 1758

Art.13(1) Zinc

Zinc has a role in the The claim may be used only for food process of cell division which is at least a source of zinc as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.

DNA synthesis and cell 2009;7(9):1229, division 2010;8(10):1819

Commission Regulation (EU) 432/2012 of 16/05/2012

Authorised

292, 293, 1759

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Cocoa flavanols

Cocoa flavanols help Information shall be given to the maintain the elasticity of consumer that the beneficial effect is blood vessels, which obtained with a daily intake of 200 mg contributes to normal of cocoa flavanols. blood flow The claim can be used only for cocoa beverages (with cocoa powder) or for dark chocolate which provide at least a daily intake of 200 mg of cocoa flavanols with a degree of polymerisation 1-10

Q-2012-00002

Commission Regulation (EU) No Authorised * 851/2013 of 03/09/2013

N/A

Art.13(5) Slowly digestible starch

Consumption of products high in slowly digestible starch (SDS) raises blood glucose concentration less after a meal compared to products low in SDS

The claim may be used only on food where the digestible carbohydrates provide at least 60 % of the total energy and where at least 55 % of those carbohydrates is digestible starch, of which at least 40 % is SDS

Q-2010-00966

Commission Regulation (EU) No Authorised * 851/2013 of 03/09/2013

N/A

Art.13(5) Reformulated, nonReplacing sugaralcoholic, acidic drink with: containing, acidic less than 1 g drinks, such as soft fermentable carbohydrate drinks (typically 8-12 g per 100 ml (sugars and sugars/100 ml), with other carbohydrates except reformulated drinks polyols), calcium in a contributes to the range from 0,3 to 0,8 mol maintenance of tooth per mol acidulant, mineralisation display of pH between 3,74,0.

In order to bear the claim, reformulated acidic drinks shall comply with the description of the food subject to the claim

Q-2010-00784

Commission Regulation (EU) No Authorised * 851/2013 of 03/09/2013

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim may be used only for food which is high in that fibre as referred to in the claim HIGH FIBRE as listed in the Annex to Regulation (EC) No 1924/2006

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Sugar beet fibre

Sugar beet fibre and increasing faecal bulk

Q-2011-00972

Commission Regulation (EU) No Authorised 40/2014 of 17/01/2014

N/A

Art.13(5) Water-Soluble Tomato Water-Soluble Tomato Concentrate (WSTC) I and Concentrate (WSTC) I II and II helps maintain normal platelet aggregation, which contributes to healthy blood flow

Information to the consumer that the beneficial effect is obtained with a daily consumption of 3g WSTC I or 150 mg WSTC II in up to 250 ml of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) or with a daily consumption of 3 g WSTC I or 150 mg WSTC II in food supplements when taken with a glass of water or other liquid.

Q-2009-00229, Q-2010-00809

Decision 2009/980/EU of 17/12/2009, Amended by Decision 2010/770/EU of 13/12/2010

Authorised *

N/A

Art.14(1)( Barley beta-glucans a)

Barley beta-glucans has Information shall be given to the been shown to consumer that the beneficial effect is lower/reduce blood obtained with daily intake of 3 g of cholesterol. High barley beta-glucan. cholesterol is a risk The claim can be used for foods which factor in the provide at least 1 g of barley betadevelopment of glucan per quantified portion. coronery heart disease

Q-2011-00799

Commission Regulation (EU) 1048/2012 of 08/11/2012

Authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Barley beta-glucans a)

Barley beta-glucans has Information shall be given to the been shown to consumer that the beneficial effect is lower/reduce blood obtained with a daily intake of 3 g of cholesterol. High barley beta-glucan. cholesterol is a risk The claim can be used for foods which factor in the provide at least 1 g of barley betadevelopment of glucan per quantified portion. coronery heart disease.

Q-2011-00798

Commission Regulation (EU) 1048/2012 of 08/11/2012

Authorised

N/A

Art.14(1)( Chewing gum sweetened Chewing gum Information to the consumer that the a) with 100% xylitol sweetened with 100% beneficial effect is obtained with a xylitol has been shown consumption of 2-3g of chewing gum to reduce dental plaque. sweetened with 100% xylitol at least 3 High content/level of times per day after the meals dental plaque is a risk factor in the development of caries in children Art.14(1)( Oat beta-glucan Oat beta-glucan has Information shall be given to the a) been shown to consumer that the beneficial effect is lower/reduce blood obtained with a daily intake of 3 g of cholesterol. High oat beta-glucan. cholesterol is a risk factor in the The claim can be used for foods which development of provide at least 1g of oat beta glucan coronary heart disease per quantified portion.

Q-2008-321

Commission Regulation (EC) No Authorised 1024/2009 of 29/10/2009

N/A

Q-2008-681

Commission Regulation (EU) 1160/2011 of 14/11/2011

Authorised

N/A

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Plant stanol esters a)

Plant stanol esters have Information to the consumer that the been shown to beneficial effect is obtained with a daily lower/reduce blood intake of 1,5-2,4 g plant stanols. cholesterol. High Reference to the magnitude of the cholesterol is a risk effect may only be made for foods factor in the within the following categories: yellow development of fat spreads, dairy products, coronary heart disease. mayonnaise and salad dressings. When referring to the magnitude of the effect, the entire range ''7 to 10 %'' and the duration to obtain the effect ''in 2 to 3 weeks'' must be communicated to the consumer.

Q-2008-118

Commission Regulation (EC) 983/2009 of 21/10/2009, Amended by Commission Regulation (EC) 376/2010 of 03/05/2010

Authorised

N/A

Art.14(1)( Plant sterols/Plant stanol a) esters

Plant sterols and plant Information to the consumer that the stanol esters have been beneficial effect is obtained with a daily shown to lower/reduce intake of 1,5-2,4 g plant blood cholesterol. High sterols/stanols. Reference to the cholesterol is a risk magnitude of the effect may only be factor in the made for foods within the following development of categories: yellow fat spreads, dairy coronary heart disease. products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the entire range '7 to 10 %' and the duration to obtain the effect 'in 2 to 3 weeks' must be communicated to the consumer

Q-2008-779

Commission Regulation (EU) 384/2010 of 05/05/2010

Authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-2,4 g plant sterols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the entire range ''7 to 10 %'' and the duration to obtain the effect ''in 2 to 3 weeks'' must be communicated to the consumer.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Plant sterols: Sterols a) extracted from plants, free or esterified with food grade fatty acids.

Plant sterols have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

Q-2008-085

Commission Regulation (EC) 983/2009 of 21/10/2009, Amended by Commission Regulation (EC) 376/2010 of 03/05/2010

Authorised

N/A

Art.14(1)( Sugar-free chewing gum a)

Sugar-free chewing Information shall be given to the gum helps neutralise consumer that the beneficial effect is plaque acids. Plaque obtained with chewing of 2-3 g of acids are a risk factor in sugar-free chewing gum for 20 the development of minutes, at least three times per day dental caries. after meals.

Q-2010-00120

Commission Regulation (EU) 665/2011 of 11/07/2011

Authorised

N/A

Art.14(1)( Sugar-free chewing gum a)

Sugar-free chewing gum helps reduce tooth demineralisation. Tooth demineralisation is a risk factor in the development of dental caries.

Information shall be given to the consumer that the beneficial effect is obtained with chewing of 2-3 g of sugar-free chewing gum for 20 minutes, at least three times per day after meals.

Q-2010-00119

Commission Regulation (EU) 665/2011 of 11/07/2011

Authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim can be used only for food which is at least a source of calcium and vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Calcium and vitamin D b)

Calcium and vitamin D are needed for normal growth and development of bone in children

Q-2008-116

Commission Regulation (EC) 983/2009 of 21/10/2009

Authorised

N/A

Art.14(1)( Calcium b)

Calcium is needed for normal growth and development of bone in children.

The claim can be used only for food which is at least a source of calcium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation 1924/2006.

Q-2008-322

Commission Regulation (EC) 983/2009 of 21/10/2009

Authorised

N/A

Art.14(1)( Docosahexaenoic acid b) (DHA)

Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age.

Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 mg of DHA. When the claim is used on follow-on formula, the food shall contain at least 0,3 % of the total fatty acids as DHA.

Q-2008-211, Q-2008-688, Q-2008-689

Commission Regulation (EU) No Authorised 440/2011 of 06/05/2011

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega3 fatty acids for adults, i.e.: 250 mg DHA and EPA. The claim can be used only for food which provides a daily intake of at least 200 mg DHA

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Docosahexaenoic acid b) (DHA)

Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain development of the foetus and breastfed infants.

Q-2008-773

Commission Regulation (EU) No Authorised 440/2011 of 06/05/2011

N/A

Art.14(1)( Docosahexaenoic acid b) (DHA)

Docosahexaenoic acid (DHA) maternal intake contributes to the normal development of the eye of the foetus and breastfed infants.

Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega3 fatty acids for adults, i.e.: 250 mg DHA and eicosapentaenoic acid (EPA). The claim can be used only for food which provides a daily intake of at least 200 mg DHA.

Q-2008-675

Commission Regulation (EU) No Authorised 440/2011 of 06/05/2011

N/A

Art.14(1)( &alpha;-linolenic acid (ALA)Essential fatty acids are Information to the consumer that the b) & linoleic acid (LA), needed for normal beneficial effect is obtained with a daily essential fatty acids growth and intake of 2 g of -linolenic acid (ALA) development of and a daily intake of 10 g of linoleic children. acid (LA).

Q-2008-079

Commission Regulation (EC) 983/2009 of 21/10/2009, Amended by Commission Regulation (EC) 376/2010 of 03/05/2010

Authorised

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Iodine b)

Iodine contributes to the The claim can be used only for food normal growth of which is at least a source of iodine as children referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006

Q-2008-324

Commission Regulation (EU) No Authorised 957/2010 of 22/10/2010

N/A

Art.14(1)( Iron b)

Iron contributes to The claim can be used only for food normal cognitive which is at least a source of iron as development of children referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006

Q-2008-325

Commission Regulation (EU) No Authorised 957/2010 of 22/10/2010

N/A

Art.14(1)( Phosphorus b)

Phosphorus is needed for the normal growth and development of bone in children

The claim can be used only for food which is at least a source of phosphorus as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation 1924/2006

Q-2008-217

Commission Regulation (EC) No Authorised 1024/2009 of 29/10/2009

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation The claim can be used only for food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as listed in the Annex to Regulation 1924/2006.

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Protein b)

Protein is needed for normal growth and development of bone in children.

Q-2008-326

Commission Regulation (EC) 983/2009 of 21/10/2009

Authorised

N/A

Art.14(1)( Vitamin D b)

Vitamin D is needed for normal growth and development of bone in children.

The claim can be used only for food which is at least a source of Vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation 1924/2006.

Q-2008-323

Commission Regulation (EC) 983/2009 of 21/10/2009

Authorised

N/A

Art.13(1) Sugar beet fibre

"- The combination of soluble / insoluble fibre in Sugar beet fibre makes the stomach work properly. - Dietary fibre helps to maintain bowel/colonic function - Dietary fibre promotes regularity - Ensures a healthy digestive system/function"

Non-compliance with the Regulation Changes in bowel because on the basis of the scientific function evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2034

Non-authorised

751

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) CalorieControl Trim Oat "The inclusion of 3 Non-compliance with the Regulation Maintenance or 2010;8(2):1482 Bran grams oat beta glucan because on the basis of the scientific achievement of normal soluble fiber per day evidence assessed, this claimed effect blood glucose from Calorie for this food has not been concentrations ControlTrim Oat Bran, substantiated. as part of a diet low in saturated fat and a healthy lifestyle, can help maintain healthy blood glucose levels. Oat beta glucan soluble fiber from Calorie ControlTrim Oat Bran, as part of a diet low in saturated fat and a healthy lifestyle, can help maintain healthy blood glucose levels. Calorie ControlTrim Oat Bran helps maintain healthy blood glucose levels."

Non-authorised

2935

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Citrus sinensis - common "Traditionally used for name : Orange the good circulation of blood in microvessels" / "Traditionally used to decrease the sensations of heavy leggs" / "Used for the good circulation of blood in microvessels" / "Helps to decrease the sensations of heavy leggs" Art.13(1) Prunus cerasus - common "Traditionally used to name : Sour cherry enhance the renal elimination of water" / "Traditionally used to facilitate the elimination functions of the organism" / "Used to enhance the renal elimination of water" / "Used to facilitate the elimination functions of the organism" / "Used for the drainage of the organism" / "Diuretic effect" / "Stimulates the elimination function of the organism" / "Contributes to the functionary of the urinary tract"

Non-compliance with the Regulation Vascular and vein because on the basis of the scientific health evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

3667

Non-compliance with the Regulation Increase in renal water 2010;8(10):1742 because on the basis of the scientific elimination evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

3693

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Prunus cerasus - common "Traditionally used to Non-compliance with the Regulation Digestive function 2011;9(6):2228 name : Sour cherry facilitate the digestion" / because on the basis of the scientific "Used to facilitate the evidence assessed, this claimed effect digestion" / "Contributes for this food is not sufficiently defined to the digestive comfort" to be able to be assessed and the / "Helps to support the claim could not therefore be digestion" / "Contributes substantiated. to support the digestion". Art.13(1) Ananas comosus "Used for the good Non-compliance with the Regulation Vascular and vein 2011;9(6):2228 common name : Bromelain,circulation of blood in because on the basis of the scientific health Pineapple microvessels" evidence assessed, this claimed effect "Helps to decrease the for this food is not sufficiently defined sensations of heavy to be able to be assessed and the leggs" claim could not therefore be substantiated. Art.13(1) Apium graveolens "Used to enhance the Non-compliance with the Regulation Increase in renal water 2010;8(10):1742 common name : celery renal elimination of because on the basis of the scientific elimination water" / "Used to evidence assessed, this claimed effect facilitate the elimination for this food is not a beneficial functions of the physiological effect as required by the organism" / "Used for Regulation. the drainage of the organism" / "Stimulates the elimination function of the organism" / "Contributes to the functionary of the urinary tract"

Non-authorised

3692

Non-authorised

2212

Non-authorised

2218

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cynara scolymus "Used to enhance the common name : artichoke, renal elimination of globe artichoke water" / "Used to facilitate the elimination functions of the organism" / "Used for the drainage of the organism" / "Stimulates the elimination function of the organism" / "Contributes to the functionary of the urinary tract"

Non-compliance with the Regulation Increase in renal water 2010;8(10):1742 because on the basis of the scientific elimination evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

2253

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Raphanus sativus common name : radish, black radish, Japanese radish, Daikon

"Used to facilitate the Non-compliance with the Regulation Digestive function 2011;9(6):2228 digestion" because on the basis of the scientific "Helps to support evidence assessed, this claimed effect normal liver function" for this food is not sufficiently defined "Contributes to the to be able to be assessed and the stimulation of the claim could not therefore be production of the substantiated. digestive body fluids" "Supports the liver and biliary function" "Contributes to the digestive comfort" "Helps to facilitate fat digestion" "Contributes to better fat digestion" "Helps to support the digestion" "Contributes to support the digestion". Art.13(1) Ananas comosus "Used to facilitate the Non-compliance with the Regulation reduction of gastro2011;9(6):2248 common name : Bromelain,digestion" / "Contributes because on the basis of the scientific intestinal discomfort Pineapple to the digestive comfort" evidence assessed, this claimed effect / "Helps to support the for this food has not been digestion" / "Contributes substantiated. to support the digestion". Art.13(1) Huile d'olive "rgule le niveau de Non-compliance with the Regulation maintenance of normal 2011;9(4):2044 sucre dans le sang" because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

2329

Non-authorised

2213

Non-authorised

4244

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium bifidum I- ' probiotic 3426 -helps to strenghten your body's natural defences; -helps to strenghten the natural defenses; '-helps to stimulate the immune system Art.13(1) Lactobacillus acidophilus '- probiotic Lafti L10 (CBS 116.411) -improves your feeling of (intestinal) comfort;

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

860

Art.13(1) Lactobacillus acidophilus (ATCC SD5221) and Bifidobacterium lactis (ATCC SD5219)

Art.13(1) Bifidobacterium animalis ssp. lactis BB-12, Lactobacillus acidophilus LA-5, Lactbacillus bulgaricus LBY-27 and Streptococcus thermophilus STY-31

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. '- probiotic Non-compliance with the Regulation not validated '- Supports your because on the basis of the scientific immune system during evidence assessed, this food is not the pollen season sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. '- probiotic Non-compliance with the Regulation not validated '-helps maintain a because on the basis of the scientific healthy gut flora evidence assessed, this food is not -helps maintain sufficiently characterised for a intestinal comfort scientific assessment of this claimed -helps support the gut effect and the claim could not therefore microflora be substantiated. -helps to reduce uncomfortable intestinal disturbances

2009;7(9):1247

Non-authorised

881

2010;8(2):1470

Non-authorised

3010

2009;7(9):1247

Non-authorised

920

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bacillus subtilis PB6

'- probiotic - for good intestinal health; - promotes and maintains intestinal health; - promotes and maintains intestinal function;

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

918

- supports healthy gastrointestinal flora; - for good digestive health; - promotes and stimulates good bowel movement; Art.13(1) Bifidobacterium longum I- '- probiotic 3470 -helps balance the intestinal flora; -helps maintain digestive health.

Art.13(1) Bifidobacterium bifidum CNCM I-373

'- probiotic -helps maintain a healthy gut flora.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

877

2009;7(9):1247

Non-authorised

861

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus CNCM I-1722

'- probiotic -helps maintain a healthy gut flora.

Art.13(1) Bifidobacterium infantis I- '- probiotic 3424 -helps maintain digestive health.

Art.13(1) Lactobacillus acidophilus CUL21 NCIMB 30156 Lactobacillus acidophilus CUL 60 NCIMB 30157 Bifibobacterium adolescentis CUL 20 NCIMB 30153 Bifiidobacterium lactis (animalis ssp. lactis) CUL 34 NCIMB 30172 Art.13(1) Saccharomyces boulardii (trade name PXN68)

'- probiotic -improves intestinal environment and functionality; -maintains healthy digestive system; -supports good digestive function; -maintains balance of healthy microflora; '- probiotic Non-compliance with the Regulation not validated -maintains the fine because on the basis of the scientific balance of the intestinal evidence assessed, this food is not microflora; sufficiently characterised for a -helps to stimulate the scientific assessment of this claimed body's natural defences;effect and the claim could not therefore be substantiated.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

879

2009;7(9):1247

Non-authorised

874

2009;7(9):1247

Non-authorised

885

2009;7(9):1247

Non-authorised

912

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei ssp. paracasei CRL-431

'- probiotic Non-compliance with the Regulation not validated -strenghten/ support because on the basis of the scientific your body's natural evidence assessed, this food is not defence; sufficiently characterised for a -strengthens and scientific assessment of this claimed protects from inside effect and the claim could not therefore -supports the balance of be substantiated. the intestinal flora thereby supporting the body's defence system Art.13(1) Lactobacillus johnsonii '- probiotic -La1 helps to Non-compliance with the Regulation protection of the skin NCC 533 (La1) (Pasteur preserve skin health. + - because on the basis of the scientific from UV-induced culture collection CNCM I- helps to reinforce skin evidence assessed, this claimed effect damage 1225) defences for this food has not been substantiated. Art.13(1) Honey 'Helps support and Non-compliance with the Regulation not validated maintain a healthy because on the basis of the scientific digestive system. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Mediterranean diet 'X' fits in a Non-compliance with the Regulation not validated Mediterranean diet. A because on the basis of the scientific Mediterranean style diet evidence assessed, this food is not helps maintain heart sufficiently characterised for a health. scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

898

2011;9(6):2231

Non-authorised

900

2011;9(6):2243

Non-authorised

1160

2011;9(6):2245

Non-authorised

1423

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Apple Flavan-3-ols

(-)-epicatechin is Non-compliance with the Regulation improvement of 2011;9(4):2065 important in maintaining because on the basis of the scientific endothelium-dependent a healthy circulation evidence assessed, this claimed effect vasodilation for this food has not been substantiated. Art.13(1) Anthocyans from elderberry(Anthocyans from) Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 juice elderberry juice help to : because on the basis of the scientific proteins and lipids from - protect cells against evidence assessed, this claimed effect oxidative damage oxidative damages for this food has not been strengthen the immune substantiated. system Art.13(1) Antioxidants from (Antioxidants from) Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 pomegranate juice pomegranate - plays an because on the basis of the scientific proteins and lipids from important antioxidative evidence assessed, this claimed effect oxidative damage function - protect cells for this food has not been against oxidative substantiated. damages - strengthen the immune system strengthen the body's defences Art.13(1) (Cows) Milk (Cows) Milk products Non-compliance with the Regulation not validated 2011;9(6):2243 And dairy products for help support dental because on the basis of the scientific which milk is the principle health. evidence assessed, this food is not ingredient and no sugar (Cows) Milk helps sufficiently characterised for a has been added e.g. support the normal and scientific assessment of this claimed yogurt, cheese. healthy development of effect and the claim could not therefore teeth. be substantiated. (Cows) Milk contributes to dental health.

Non-authorised

1936

Non-authorised

1940

Non-authorised

1941

Non-authorised

1141

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cryptoxanthin from orange (Cryptoxanthin from) Non-compliance with the Regulation Immune 2011;9(4):2061 juice orange juice participate because on the basis of the scientific function/immune to strengthen immune evidence assessed, this claimed effect system system. for this food is not sufficiently defined Clarification provided to be able to be assessed and the (Cryptoxanthin from) claim could not therefore be orange juice ensure substantiated. antioxidant action / ensure protective effect on the organism. Art.13(1) Lycopenes from tomato (Lycopenes from) Non-compliance with the Regulation protection of DNA, 2011;9(4):2031 juice tomato juice: - plays an because on the basis of the scientific proteins and lipids from important antioxidative evidence assessed, this claimed effect oxidative damage function - protect cells for this food has not been against oxidative substantiated. damages - strengthen the immune system strengthen the body's defences Art.13(1) Lactobacillus delbrueckii * Aumenta la normale Non-compliance with the Regulation not validated 2009;7(9):1247 subsp. bulgaricus AY/CSL risposta immunitaria * because on the basis of the scientific (LMG-P 17224) and contribuisce all'aumento evidence assessed, this food is not Streptococcus delle difese immunitarie sufficiently characterised for a thermophilus 9Y/CSL (LMG* contribuisce scientific assessment of this claimed -P 17225) all'aumento delle difese effect and the claim could not therefore naturali * aiuta ad be substantiated. accresce le difese dell'organismo

Non-authorised

1939

Non-authorised

1942

Non-authorised

2954

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hyperproteins pasta (FPP-P-0702)

* Foods rich in protein help you to feel you satiate longer so as to help you to manage your weight. * Proteins promotes satiety. * Diets rich in protein and poor in carbohydrate affect positively body mass and body composition. * Loss higher in fat and loss limited in muscle mass. * Diets with high protein/carbohydrate ratio have a positive effect on body composition.

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2010;8(10):1811

Non-authorised

616

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hyperproteins pasta (FPP-P-0702)

Art.13(1) Bifidobacterium animalis ssp. lactisTHT 010801

Art.13(1) Bifidobacterium animalis ssp. lactisTHT 010801

* Foods rich in protein help you to feel you satiate longer so as to help you to manage your weight. * Proteins promotes satiety. * Diets rich in protein and poor in carbohydrate affect positively body mass and body composition. * Loss higher in fat and loss limited in muscle mass. * Diets with high protein/carbohydrate ratio have a positive effect on body composition. * Helps to improve intestinal transit * Helps to reduce natural digestion * Helps to regulate intestinal flora * Promotes intestinal comfort * Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism

Non-compliance with the Regulation increase in satiety 2010;8(10):1811 because on the basis of the scientific leading to a reduction in evidence assessed, this claimed effect energy intake for this food has not been substantiated.

Non-authorised

616

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 961 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2857

Non-authorised 962 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium longum THT 010301

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

* Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism Bifidobacterium longum bv * Helps to strengthen infantis THT 010201 natural defences * Stimulates immune system * Strengthens resistance of organism Bifidobacterium * Helps to strengthen pseudolongum ssp natural defences pseudolongum THT * Stimulates immune 010501 system * Strengthens resistance of organism Lactobacillus casei THT * Helps to strengthen 030401 natural defences * Stimulates immune system * Strengthens resistance of organism Lactobacillus gasseri THT * Helps to strengthen 031301 natural defences * Stimulates immune system * Strengthens resistance of organism

Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2857

Non-authorised 970 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 968 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 972 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 976 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 984 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus helveticus THT 031102

Art.13(1) Lactobacillus plantarum THT 030701

Art.13(1) Lactobacillus plantarum THT 030707

Art.13(1) Lactobacillus reuteri THT 030802

Art.13(1) Lactobacillus salivarius THT 031001

* Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism * Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism * Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism * Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism * Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism

Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2857

Non-authorised 986 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 995 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 997 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 999 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 1007 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus * Helps to strengthen thermophilus THT 070102 natural defences * Stimulates immune system * Strengthens resistance of organism Art.13(1) Bifidobacterium animalis * Helps to strengthen ssp animalis THT 010401 natural defences * Stimulates immune system * Strengthens resistance of organism

Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2857

Non-authorised 1015 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Bifidobacterium bifidum * Helps to strengthen Non-compliance with the Regulation not validated THT 010101 natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated. Art.13(1) Bifidobacterium breve THT * Helps to strengthen Non-compliance with the Regulation not validated 010601 natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

959

2009;7(9):1247

Non-authorised

964

2009;7(9):1247

Non-authorised

966

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus THT 030102

* Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism

Art.13(1) Lactobacillus delbrucki bulgaricus THT 030302

Art.13(1) Lactobacillus delbrucki bulgaricus THT 030303

Art.13(1) Lactobacillus helveticusTHT 031101

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

974

2009;7(9):1247

Non-authorised

980

2009;7(9):1247

Non-authorised

982

2009;7(9):1247

Non-authorised

988

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus reuteri THT 030803

* Helps to strengthen natural defences * Stimulates immune system * Strengthens resistance of organism

Art.13(1) Lactobacillus rhamnosus THT 030901

Art.13(1) Lactobacillus rhamnosus THT 030902

Art.13(1) Lactococcus lactis THT 090101

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1001

2009;7(9):1247

Non-authorised

1003

2009;7(9):1247

Non-authorised

1005

2009;7(9):1247

Non-authorised

1009

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus * Helps to strengthen thermophilus THT 070101 natural defences * Stimulates immune system * Strengthens resistance of organism Art.13(1) Lactobacillus delbrucki bulgaricus THT 030301

Art.13(1) Bifidobacterium animalis ssp. lactisTHT 010801

Art.13(1) Bifidobacterium animalis ssp. lactisTHT 010801

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. * Helps to strengthen Non-compliance with the Regulation not validated natural defences because on the basis of the scientific * Stimulates immune evidence assessed, this food is not system sufficiently characterised for a * Strengthens scientific assessment of this claimed resistance of organism effect and the claim could not therefore be substantiated. * Maintains/restores the Non-compliance with the Regulation Changes in bowel balance of intestinal because on the basis of the scientific function, and digestion flora evidence assessed, this claimed effect and absorption of * Promotes intestinal for this food has not been nutrients comfort substantiated. * Strengthens resistance of organism * Improves digestive health * Maintains/restores the Non-compliance with the Regulation Decreasing potentially balance of intestinal because on the basis of the scientific pathogenic gastroflora evidence assessed, this claimed effect intestinal * Promotes intestinal for this food has not been microorganisms comfort substantiated. * Strengthens resistance of organism * Improves digestive health

2009;7(9):1247

Non-authorised

1013

2009;7(9):1247

Non-authorised

978

2009;7(9):1247, 2012;10(8):2857

Non-authorised 960 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2857

Non-authorised 960 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium longum THT 010301

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Bifidobacterium longum * Maintains/restores the THT 010301 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Bifidobacterium longum bv * Maintains/restores the infantis THT 010201 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 969 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 969 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 967 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium longum bv * Maintains/restores the infantis THT 010201 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Bifidobacterium * Maintains/restores the pseudolongum ssp balance of intestinal pseudolongum THT flora 010501 * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Bifidobacterium * Maintains/restores the pseudolongum ssp balance of intestinal pseudolongum THT flora 010501 * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 967 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 971 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 971 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus casei THT 030401

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus casei THT * Maintains/restores the 030401 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus gasseri THT * Maintains/restores the 031301 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 975 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 975 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 983 (expiry of transitional period 02/01/2014)

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Page 116

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri THT * Maintains/restores the 031301 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus helveticus * Maintains/restores the THT 031102 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus helveticus * Maintains/restores the THT 031102 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 983 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 985 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 985 (expiry of transitional period 02/01/2014)

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Page 117

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum THT 030701

Art.13(1) Lactobacillus plantarum THT 030701

Art.13(1) Lactobacillus plantarum THT 030707

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 994 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 994 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 996 (expiry of transitional period 02/01/2014)

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Page 118

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum THT 030707

Art.13(1) Lactobacillus reuteri THT 030802

Art.13(1) Lactobacillus reuteri THT 030802

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 996 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 998 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 998 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus salivarius THT 031001

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus salivarius * Maintains/restores the THT 031001 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Streptococcus * Maintains/restores the thermophilus THT 070102 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 1006 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 1006 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Changes in bowel 2009;7(9):1247, because on the basis of the scientific function, and digestion 2012;10(8):2857 evidence assessed, this claimed effect and absorption of for this food has not been nutrients substantiated.

Non-authorised 1014 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus * Maintains/restores the thermophilus THT 070102 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Bifidobacterium animalis * Maintains/restores the ssp animalis THT 010401 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Bifidobacterium bifidum * Maintains/restores the THT 010101 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2857 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 1014 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

958

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

963

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium breve THT * Maintains/restores the 010601 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus delbrucki * Maintains/restores the bulgaricus THT 030301 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus delbrucki * Maintains/restores the bulgaricus THT 030302 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

965

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

977

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

979

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus delbrucki bulgaricus THT 030303

Art.13(1) Lactobacillus helveticusTHT 031101

Art.13(1) Lactobacillus reuteri THT 030803

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

981

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

987

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1000

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus THT 030901

Art.13(1) Lactobacillus rhamnosus THT 030902

Art.13(1) Lactococcus lactis THT 090101

* Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health * Maintains/restores the balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1002

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1004

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1008

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus * Maintains/restores the thermophilus THT 070101 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Improves digestive health Art.13(1) Lactobacillus acidophilus * Maintains/restores the THT 030102 balance of intestinal flora * Promotes intestinal comfort * Strengthens resistance of organism * Promotes intestinal well-being * Improves digestive health

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1012

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

973

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Raw or processed food * The Tradilin network Non-compliance with the Regulation not validated products of animal origin, makes it possible to because on the basis of the scientific plus bread and panification obtain products which fit evidence assessed, this food is not products (cows, goats into a diet naturally rich sufficiently characterised for a and ewes milk and related in omega 3 which scientific assessment of this claimed products ( milk, cream, participates to effect and the claim could not therefore butter, cheese, yoghurt, improve/decrease be substantiated. fresh dairy products); hens carbohydrate metabolic and quails eggs; beefs, disorders veals and lambs me La filire Tradilin permet dobtenir des produits qui sintgrent dans une alimentation riche en Omga 3 qui participe diminuer les dsordres du mtabolisme des carbohydrates * The Tradilin network makes it possible to obtain products which fit into a diet naturally rich in omega 3 which participates in the control of parameters of the metabolic syndrome La filire Tradilin permet dobtenir des produits qui sintgrent dans une alimentation riche en Omga 3 qui participe au contrle des paramtres du

2011;9(6):2243

Non-authorised

1194

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

syndrome mtabolique * This product participates/contributes/ helps to regulate carbohydrate metabolism Ce produit participe la rgulation du mtabolisme glucidique * This product, from the Tradilin network, helps to better to regulate carbohydrate metabolism/ control the parameters on the metabolic syndrome Ce produit, issu de la filire Tradilin, sintgre dans une alimentation riche en Omga 3 qui participe diminuer les dsordres du mtabolisme des carbohydrates/ contrler les paramtres du syndrome mtabolique

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Raw or processed food * The Tradilin network Non-compliance with the Regulation not validated products of animal origin, makes it possible to because on the basis of the scientific plus bread and panification obtain products which fit evidence assessed, this food is not products (cows, goats into a diet naturally rich sufficiently characterised for a and ewes milk and related in omega 3, which scientific assessment of this claimed products ( milk, cream, favors the balance/a effect and the claim could not therefore butter, cheese, yoghurt, good balance of blood be substantiated. fresh dairy products); hens lipids and quails eggs; beefs, La filire Bleu-Blancveals and lambs me Coeur / Tradilin permet dobtenir des produits qui sintgrent dans une alimentation naturellement riche en omga 3, qui favorise lquilibre des lipides sanguins * A diet which includes products from the Tradilin network favours a good balance of blood lipids. Salimenter avec des produits, issus de la filire Tradilin favorise lquilibre des lipides sanguins * This product participates/ contributes to improve the balance of blood lipids. Ce produit

2011;9(6):2243

Non-authorised

1193

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

contribue/participe lamlioration de lquilibre des lipides sanguins * This product, from de Tradilin network fits in a diet naturally increased in Omega 3, which favors the balance of blood lipids Ce produit, issu de la filire Tradilin sintgre dans une alimentation naturellement riche en Omga 3, qui favorise lquilibre des lipides sanguins Art.13(1) Lactobacillus delbrueckii * beneficially affects the subsp. bulgaricus AY/CSL intestinal microflora * (LMG-P 17224) and balances the intestinal Streptococcus microflora * enhances thermophilus 9Y/CSL (LMGlevels of beneficial -P 17225) microflora * improves intestinal microflora in elderly

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

2953

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus K8 (LMG P-17503)

* helps to restore and Non-compliance with the Regulation not validated maintain a normal because on the basis of the scientific vaginal microflora * evidence assessed, this food is not helps during the sufficiently characterised for a treatment of urogenital scientific assessment of this claimed disorders * supports effect and the claim could not therefore epithelial immunity * be substantiated. helps to maintains the vaginal natural ecosystem. Art.13(1) Lactobacillus delbrueckii * specific bacteria Non-compliance with the Regulation not validated subsp. bulgaricus AY/CSL improve lactose because on the basis of the scientific (LMG-P 17224) and digestion *specific evidence assessed, this food is not Streptococcus bacteria in yogurt helps sufficiently characterised for a thermophilus 9Y/CSL (LMGthe lactose digestion in scientific assessment of this claimed -P 17225) people with lactose effect and the claim could not therefore malabsorption. be substantiated. Art.13(1) Lactobacillus casei 101/37 *Help to strenghten Non-compliance with the Regulation not validated (LMG P-17504) immune system * help because on the basis of the scientific to strenghten the body's evidence assessed, this food is not natural defenses * sufficiently characterised for a favours a barrier effect scientific assessment of this claimed before potentially effect and the claim could not therefore pathogenic be substantiated. microorganisms * balances the intestinal microflora * contribute to maintain the intestinal natural flora.

2010;8(2):1470

Non-authorised

2943

2009;7(9):1247

Non-authorised

2955

2010;8(2):1470

Non-authorised

3034

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium infantis Bi1 *balances your Non-compliance with the Regulation not validated (LMG P-17502), intestinal microflora * because on the basis of the scientific Bifidobacterium breve Bbr8 promotes and maintains evidence assessed, this food is not (LMG P-17501) and intestinal health * sufficiently characterised for a Bifidobacterium longum promotes and maintains scientific assessment of this claimed Bl10 (LMG P-17500) intestinal function * effect and the claim could not therefore supports healthy be substantiated. gastrointestinal flora Art.13(1) Lactobacillus acidophilus *balances your Non-compliance with the Regulation not validated LA1 (LMG P-21904) intestinal microflora * because on the basis of the scientific promotes and maintains evidence assessed, this food is not intestinal health * sufficiently characterised for a promotes and maintains scientific assessment of this claimed intestinal function * effect and the claim could not therefore supports healthy be substantiated. gastrointestinal flora *reduces occurence of antibiotic resistant bacteria in the gut flora * contribute to a b

2010;8(2):1470

Non-authorised

2939

2010;8(2):1470

Non-authorised

2945

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Alpha Lipoic acid (ALA)

Art.13(1) Sugar-free chewing gum

Art.13(1) Whey Protein

- ALA supports the Non-compliance with the Regulation Maintenance of normal 2010;8(2):1474 decrease of the blood because on the basis of the scientific blood glucose sugar, might regulate evidence assessed, this claimed effect concentrations the insulin resistance; for this food has not been - ALA has proven to be substantiated. very effective in protection from glycation; - ALA might help to regulate the damage done by final products of the glycation proteins (AGE). - Beneficial to dental Non-compliance with the Regulation dental and oral health, 2009;7(9):1271 health; because on the basis of the scientific including gum and tooth - safe for teeth; evidence assessed, this claimed effect protection and strength promotes healthy teeth for this food is not sufficiently defined and gums; -helps to be able to be assessed and the protect teeth and gums; claim could not therefore be -helps to strengthen substantiated. teeth and gums. - Combined with Non-compliance with the Regulation increase in muscle 2010;8(10):1818 resistance exercise, because on the basis of the scientific strength whey protein supports evidence assessed, this claimed effect an increase in muscular for this food has not been strength. substantiated. - Whey protein improves exercise performance.

Non-authorised

3162

Non-authorised

1149

Non-authorised

422

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

- Constituent of Non-compliance with the Regulation increased attention gluthathione, purines, because on the basis of the scientific amino sugars, precursor evidence assessed, this claimed effect of GABA (g-amino for this food has not been butyric acid)/supports substantiated. concentration and mental performance under conditions of mental or physical exertion/ - helps to maintain working memory and brain performance in aging adults/plays an important role in healthy nerve function through the central nervous system including the brain

2011;9(6):2225

Non-authorised

700

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

- Constituent of Non-compliance with the Regulation improvement of working 2011;9(6):2225 gluthathione, purines, because on the basis of the scientific memory amino sugars, precursor evidence assessed, this claimed effect of GABA (g-amino for this food has not been butyric acid)/supports substantiated. concentration and mental performance under conditions of mental or physical exertion/ - helps to maintain working memory and brain performance in aging adults/plays an important role in healthy nerve function through the central nervous system including the brain

Non-authorised

700

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

Art.13(1) Alpha-lipoic-acid

- Constituent of Non-compliance with the Regulation maintenance of normal 2011;9(6):2225 gluthathione, purines, because on the basis of the scientific neurological function amino sugars, precursor evidence assessed, this claimed effect of GABA (g-amino for this food has not been butyric acid)/supports substantiated. concentration and mental performance under conditions of mental or physical exertion/ - helps to maintain working memory and brain performance in aging adults/plays an important role in healthy nerve function through the central nervous system including the brain - Contributes to glucose Non-compliance with the Regulation Maintenance of normal 2010;8(2):1474 metabolism; because on the basis of the scientific blood glucose - Contributes to evidence assessed, this claimed effect concentrations maintain healthy blood for this food has not been glucose levels. substantiated.

Non-authorised

700

Non-authorised

1435

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Caffeine

Art.13(1) Vaccinium macrocarpon (Common Name : Cranberry)

- Contributes to the mobilisation of fat stores; - Contributes ton the stimulation of fat release; - Helps to increase fat burning; - Contributes to the oxidation of stored fats; - Helps generate a negative energy balance; - Contributes to increased calorie burning. - Contributes to the natural defences of the body - support of the bodys defence - supports the immune system

Non-compliance with the Regulation increased fat oxidation 2011;9(4):2054 because on the basis of the scientific leading to a reduction in evidence assessed, this claimed effect body fat mass for this food has not been substantiated.

Non-authorised

1484

Non-compliance with the Regulation Immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(4):2061

Non-authorised

2155, 3896

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Art.13(1) Wheat Dextrin

- Diet rich in fiber can help you maintain good cardiovascular health. - Dietary fiber helps maintain healthy cholesterol levels to promote overall heart health. - Dietary fiber helps maintain healthy blood pressure to promote overall heart health. -Diets rich in fiber can help promote healthy triglyceride levels. - Diet rich in fiber can help you maintain good cardiovascular health. - Dietary fiber helps maintain healthy cholesterol levels to promote overall heart health. - Dietary fiber helps maintain healthy blood pressure to promote overall heart health. -Diets rich in fiber can help promote healthy triglyceride levels.

Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 because on the basis of the scientific (fasting) blood evidence assessed, this claimed effect concentrations of for this food has not been triglycerides substantiated.

Non-authorised

844

Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

844

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

- Diet rich in fiber can help you maintain good cardiovascular health. - Dietary fiber helps maintain healthy cholesterol levels to promote overall heart health. - Dietary fiber helps maintain healthy blood pressure to promote overall heart health. -Diets rich in fiber can help promote healthy triglyceride levels.

Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 because on the basis of the scientific blood pressure evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

844

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Ipriflavone

- Exact wording of claim Non-compliance with the Regulation maintenance of bone as it appears on because on the basis of the scientific mineral density product: Ipriflavone evidence assessed, this claimed effect Description of food in termssupresses bone for this food has not been of food legislation resorption; substantiated. categories: Food - Examples of any supplement alternative wording that may be used in relation Was food on Irish market to claim: Increases before 1st July 2007: No bone density/ prevents decreased bone mineral density/ prevents rapid bone loss/ total bone health/ Maintain healthy bones/ Maintain bone integrity/ Reduce bone loss/ Maintain adequate bone density/ support bone health/ contributes to bone health/ contributes to bone strength/ Beneficial effects on bone health/ increased bone mineral density/ Increased bone strength/ Helps reduce risk of bone loss - Is claim a picture: No

2009;7(9):1267

Non-authorised

1872

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Green-lipped mussel (Perna canaliculus)

Art.13(1) L- theanine

Art.13(1) Folic acid (syn.: Vitamin B9)

- For supportive tissue Non-compliance with the Regulation maintenance of joints, 2009;7(9):1265 health; because on the basis of the scientific bone and muscles - for the promotion of evidence assessed, this claimed effect joint, bone and muscle for this food has not been functioning and mobility; substantiated. - for joint well-being. - Help learning Non-compliance with the Regulation improvement of 2011;9(6):2238 performance. because on the basis of the scientific cognitive function - Help to improve evidence assessed, this claimed effect concentration. for this food has not been - Help to improve substantiated. attention. - Sports support - Helps keep Non-compliance with the Regulation function of blood 2009;7(9):1213 arteries/blood vessels because on the basis of the scientific vessels healthy; - Contributes to evidence assessed, this claimed effect healthy arteries/ blood for this food has not been vessels; - Supports substantiated. heart health by contributing to the normal functioning of the arteries/blood vessels; - Helps maintain a normal blood pressure by supporting the elasticity of blood vessels/arteries;

Non-authorised

1813

Non-authorised

1600

Non-authorised

175

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Taurine

Art.13(1) Taurine

- Helps to delay the Non-compliance with the Regulation delay in the onset of 2009;7(9):1260 onset of fatigue; because on the basis of the scientific fatigue and - helps to maintain evidence assessed, this claimed effect enhancement of energy levels for for this food has not been physical performance prolonged periods substantiated. during intense competition / exercise; - enhances endurance and helps to maintain peak effort during times of high physical demand. - Helps to protect body Non-compliance with the Regulation protection of DNA, 2009;7(9):1260 cells; because on the basis of the scientific proteins and lipids from - Helps to protect from evidence assessed, this claimed effect oxidative damage radicals which cause for this food has not been cell oxidation; substantiated. - Helps to protect cells and tissues from oxidation; - Contributes to the total antioxidant capacity of the body.

Non-authorised

1660

Non-authorised

612

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cocoa (Theobroma cacao - Helps to support L.) slimming; - helps to support in weight loss programs; - contributes to body weight control; - helps to support lipid degradation; - contributes to fat metabolism, which helps weight control; - helps to promote weight loss; - helps in weight management. Art.13(1) Chondroitin - Helps to supports the mobility of the joints; - helps keep joints supple and flexible; - an important component of the joint metabolism.

Non-compliance with the Regulation maintenance or because on the basis of the scientific achievement of a evidence assessed, this claimed effect normal body weight for this food has not been substantiated.

2009;7(9):1300

Non-authorised

2724

Non-compliance with the Regulation maintenance of joints because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1262

Non-authorised

1504

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Guar Gum

- Low glycemic diet helps maintain insulin sensitivity - Low glycemic diet helps in the management of regular blood glucose levels - Low glycemic diet helps maintain and improve blood glucose control - Low glycemic diet supports body weight regulation Art.13(1) Lactobacillus plantarum - Maintains/restores the BFE 1685 balance of intestinal flora. - Promotes intestinal comfort. Strengthens resistance of organism - Improves digestive health Art.13(1) Green Lipped Mussel - May help to maintain Extract.A freeze dried healthy joints; powder extract of New - helps to maintain joint Zealand Green Lipped mobility; Mussel Perna canaliculus - helps keep joints supple and flexible. Art.13(1) L-Theanine - Neuroprotective. - Brain support

Non-compliance with the Regulation Maintenance of normal 2010;8(2):1464 because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

794

Non-compliance with the Regulation Decreasing potentially 2010;8(2):1471 because on the basis of the scientific pathogenic intestinal evidence assessed, this claimed effect microorganisms for this food has not been substantiated.

Non-authorised

992

Non-compliance with the Regulation maintenance of joints, 2009;7(9):1265 because on the basis of the scientific bone and muscles evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation alleviation of because on the basis of the scientific psychological stress evidence assessed, this claimed effect for this food has not been substantiated. 2011;9(6):2238

Non-authorised

1571

Non-authorised

1601

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-Theanine

Non-compliance with the Regulation improvement of because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Polyphenols from - Polyphenols contained Non-compliance with the Regulation not validated processed fruits and in this product ensure because on the basis of the scientific vegetables and juices antioxidant action; evidence assessed, this food is not - Protects the cells; sufficiently characterised for a - Antioxidant properties, scientific assessment of this claimed with natural fruit effect and the claim could not therefore antioxidants; be substantiated. - Polyphenols contained in this product ensure protective effect on the organism; - Antioxidant/s. Art.13(1) Polyphenols (general and - Polyphenols contained Non-compliance with the Regulation not validated from grape, olive and in this product ensure because on the basis of the scientific cacao in particular) antioxidant action; evidence assessed, this food is not - help prevent tissue sufficiently characterised for a oxidation; scientific assessment of this claimed - helps guard against effect and the claim could not therefore oxydation caused by be substantiated. free radicals; - have an antioxidant effect; - help mop up free radicals in cells/ antioxidants.

- Neuroprotective. - Brain support

2011;9(6):2238

Non-authorised

1601

2011;9(4):2082

Non-authorised

1636

2011;9(4):2082

Non-authorised

1637

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Polyphenols from tea

- Polyphenols contained Non-compliance with the Regulation not validated 2011;9(4):2082 in this product ensure because on the basis of the scientific antioxidant action; evidence assessed, this food is not - polyphenols contained sufficiently characterised for a in this product ensure scientific assessment of this claimed protective effect on the effect and the claim could not therefore organism; be substantiated. - contains antioxidant/s; - is a source of antioxidant/s; - with antioxidant/s. Art.13(1) Taurine - Possesses antioxidant Non-compliance with the Regulation protection of DNA, 2009;7(9):1260 and detoxifying because on the basis of the scientific proteins and lipids from properties; evidence assessed, this claimed effect oxidative damage - can protect from free for this food has not been radical which cause cell substantiated. damage, due to its antioxidant properties; - can protect cells and tissues from oxidative damages. Art.13(1) Melon extract (containing - Protects organism Non-compliance with the Regulation protection of DNA, 2010;8(10):1753 SOD) /Wheat Gliadin against effects of the because on the basis of the scientific proteins and lipids from free radicals in excess evidence assessed, this claimed effect oxidative damage during oxidative stress. for this food has not been - Protects against substantiated. cellular ageing induced by free radicals

Non-authorised

1643

Non-authorised

1959

Non-authorised

3159

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Huile de noisettes : Hazel - Provides an essential Non-compliance with the Regulation maintenance of skin 2009;7(9):1286 nut (Corylus avellana) oil fatty acid entering the because on the basis of the scientific composition of the evidence assessed, this claimed effect scalp; for this food has not been - provides an essential substantiated. fatty acid entering the composition of the skin. Art.13(1) Melon extract (containing - Quenches excess free Non-compliance with the Regulation protection of DNA, 2010;8(10):1753 SOD) /Wheat Gliadin radicals such as from because on the basis of the scientific proteins and lipids from pollutants evidence assessed, this claimed effect oxidative damage - The anti-ageing for this food has not been catalyst substantiated. - Fights premature ageing - Fights the signs of premature ageing - The anti-premature ageing catalyst Art.13(1) Melon extract (containing - Quenches excess free Non-compliance with the Regulation protection of the skin 2010;8(10):1753 SOD) /Wheat Gliadin radicals such as from because on the basis of the scientific from photo-oxidative pollutants evidence assessed, this claimed effect (UV-induced) damage - The anti-ageing for this food has not been catalyst substantiated. - Fights premature ageing - Fights the signs of premature ageing - The anti-premature ageing catalyst

Non-authorised

2749

Non-authorised

2305

Non-authorised

2305

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Melon extract (containing - Reinforces the bodys SOD) /Wheat Gliadin own natural defences. - Promotes the whole natural defences against free radicals in excess - Helps maintain the immune system Art.13(1) Melon extract (containing - Reinforces the bodys SOD) /Wheat Gliadin own natural defences. - Promotes the whole natural defences against free radicals in excess - Helps maintain the immune system Art.13(1) Vitamin B2 - Riboflavin is needed/important for mental function and performance Art.13(1) Selenium

Non-compliance with the Regulation protection of DNA, 2010;8(10):1753 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

2304, 3160

Non-compliance with the Regulation "effects on immune because on the basis of the scientific system" evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1753

Non-authorised

2304, 3160

Non-compliance with the Regulation contribution to normal 2010;8(10):1814 because on the basis of the scientific psychological functions evidence assessed, this claimed effect for this food has not been substantiated. - Selenium for a healthy Non-compliance with the Regulation prostate function 2009;7(9):1220 prostate because on the basis of the scientific - Selenium is beneficial evidence assessed, this claimed effect for prostate health for this food has not been substantiated.

Non-authorised

32

Non-authorised

284

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sugar-free chewing gum containing polyols

Art.13(1) Taurine

Art.13(1) Taurine

- Sugar-free chewing gum may be useful in weight management; - sugar-free chewing gum helps maintain your body weight (as part of a calorie controlled diet); - chewing gum helps to reduce appetite or hunger. - Supports the protection of the bodys cells; - Supports the protection from free radicals; - Supports the protection of cells and tissues from oxidation. - Taurine is important for the energy metabolism; - the transformation of food into energy.

Non-compliance with the Regulation maintenance of the because on the basis of the scientific normal body weight evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1271

Non-authorised

1152

Non-compliance with the Regulation protection of DNA, 2009;7(9):1260 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1658

Non-compliance with the Regulation energy-yielding because on the basis of the scientific metabolism evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1260

Non-authorised

614

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Art.13(1) Whey Protein

- Wheat dextrin has low glycemic and insulinemic indices and it is suitable for use by diabetics. - Eating a diet high in fiber can help control postprandial glucose levels and serum lipid profiles. - Dietary fiber helps improve glycemic control to improve your ability to maintain normal blood sugar and insulin levels, essential for good health - Whey protein can reduce muscle loss when dieting. - Whey protein offers a nutritional advantage towards achieving a desirable body composition by supporting your fat loss goals and fueling muscle growth during energy restriction.

Non-compliance with the Regulation reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated.

2010;8(10):1761

Non-authorised

845

Non-compliance with the Regulation increase in lean body because on the basis of the scientific mass during energy evidence assessed, this claimed effect restriction and for this food has not been resistance training substantiated.

2010;8(10):1818

Non-authorised

421

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Art.13(1) Whey Protein

- Whey protein can Non-compliance with the Regulation reduction of body fat reduce muscle loss because on the basis of the scientific mass during energy when dieting. evidence assessed, this claimed effect restriction and - Whey protein offers a for this food has not been resistance training nutritional advantage substantiated. towards achieving a desirable body composition by supporting your fat loss goals and fueling muscle growth during energy restriction. - Whey protein essential Non-compliance with the Regulation faster recovery from amino acids aid muscle because on the basis of the scientific muscle fatigue after fatigue recovery. evidence assessed, this claimed effect exercise - Whey protein supports for this food has not been muscle repair following substantiated. resistance training. - Whey protein accelerates recovery from exercise. - Whey protein, consumed post each exercise bout, prolongs endurance perform

2010;8(10):1818

Non-authorised

421

2010;8(10):1818

Non-authorised

428

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Art.13(1) Whey Protein

- Whey protein essential Non-compliance with the Regulation increase in endurance 2010;8(10):1818 amino acids aid muscle because on the basis of the scientific capacity during the fatigue recovery. evidence assessed, this claimed effect subsequent exercise - Whey protein supports for this food has not been bout after strenuous muscle repair following substantiated. exercise resistance training. - Whey protein accelerates recovery from exercise. - Whey protein, consumed post each exercise bout, prolongs endurance perform - Whey protein essential Non-compliance with the Regulation skeletal muscle tissue 2010;8(10):1818 amino acids aid muscle because on the basis of the scientific repair fatigue recovery. evidence assessed, this claimed effect - Whey protein supports for this food has not been muscle repair following substantiated. resistance training. - Whey protein accelerates recovery from exercise. - Whey protein, consumed post each exercise bout, prolongs endurance perform

Non-authorised

428

Non-authorised

428

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Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Art.13(1) Whey Protein

- Whey protein essential Non-compliance with the Regulation growth or maintenance 2010;8(10):1818 amino acids aid muscle because on the basis of the scientific of muscle mass maintenance in the evidence assessed, this claimed effect elderly and at risk for this food has not been persons. substantiated. - Whey protein essential amino acids reduce lean tissue loss in the elderly and at risk persons. - Whey protein leaves Non-compliance with the Regulation increase in satiety 2010;8(10):1818 you feeling fuller for because on the basis of the scientific leading to a reduction in longer, making it easier evidence assessed, this claimed effect energy intake to control your appetite for this food has not been at the next meal. substantiated. - Whey protein promotes satiety. - The intake of whey protein & its essential amino acids can promote satiety and aid in the regulation of blood glucose. - Leucine-rich whey protein promotes satiety & weight loss. - Whey protein helps you feel fuller for longer, increasing the sense of satiety.

Non-authorised

426

Non-authorised

425

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein Milk Mineral - Whey protein milk Non-compliance with the Regulation contribution to the Complex mineral complex helps because on the basis of the scientific maintenance or promote fat loss. evidence assessed, this claimed effect achievement of a - Whey protein milk for this food has not been normal body weight mineral complex helps substantiated. maintain lean body mass. - Whey protein milk mineral complex helps maintain lean body mass whilst reducing body fat. - Whey protein milk mineral complex promotes satiety. - Whey protein milk mineral complex contains ACE inhibitory peptides which influence fat metabolism.Whey protein milk mineral complex helps maintain bone mineral density. Art.13(1) Omega-3 and Omega-6 - Yes Richtiges Non-compliance with the Regulation contribution to normal fatty acids Verhltnis von omega-3 because on the basis of the scientific cognitive function (GLA) und omega-6 evidence assessed, this claimed effect Fettsuren zugunsten for this food has not been der omega-3 Fettsuren substantiated. - 100-3000mg EPA+DHA per day

2010;8(10):1818

Non-authorised

1683

2011;9(6):2224

Non-authorised

532

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus LR 04 (DSM 16605)

- assists autochthonous Non-compliance with the Regulation not validated intestinal flora in because on the basis of the scientific controlling episodes of evidence assessed, this food is not diarrhoea;- assists sufficiently characterised for a autochthonous intestinal scientific assessment of this claimed flora in controlling effect and the claim could not therefore episodes of diarrhoea in be substantiated. children;- rebalances the intestinal motility function;- rebalances the intestinal motil Art.13(1) Lactobacillus salivarius - capable of colonising Non-compliance with the Regulation not validated subsp. salivarius CRL 1328oropharyngeal mucosa because on the basis of the scientific for its enhanced ability evidence assessed, this food is not to adhere to epithelial sufficiently characterised for a cells, constituting a scientific assessment of this claimed barrier against effect and the claim could not therefore infections;- helps to be substantiated. restore and maintain normal vaginal microflora;- produces natural substances (bacteriocin-like) that

2010;8(2):1470

Non-authorised

3062

2010;8(2):1470

Non-authorised

3045

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus LR 04 (DSM 16605)

Art.13(1) Bifidobacterium longum W11(LMG P-21586)

- coadiuva la flora intestinale autoctona nella regolazione delle situazioni diarroiche; riequilibria la funzione motoria intestinale, in particolare nelle donne e nell'anziano; favorisce il mantenimento dell'omeostasi intestinale; - riequilibria la composizione della microflora dopo trattamento con antibiotici. - contributes to the rebalancing of intestinal microflora;- rebalances the intestinal motility function;- supports the maintenance of intestinal homeostasis;promotes the wellbeing of the intestine;contributes to reducing gastro-intestinal discomfort;

Non-compliance with the Regulation Lactobacillus 2010;8(2):1470, because on the basis of the scientific rhamnosus LR04 2012;10(8):2854 evidence assessed, this food is not related to the following sufficiently characterised for a claimed effect: 'reduce scientific assessment of this claimed the daily number of effect and the claim could not therefore bowel movements' be substantiated.

Non-authorised 2969 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Bifidobacterium longum 2010;8(2):1470, because on the basis of the scientific W11 related to the 2012;10(8):2854 evidence assessed, this food is not following claimed effect: sufficiently characterised for a 'relief of abdominal scientific assessment of this claimed discomfort and bloating' effect and the claim could not therefore be substantiated.

Non-authorised 3056 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus casei LC 01(CNCM I-1572)

Art.13(1) Lactobacillus paracasei LPC 01(CNCM I-1390)

- contributes to the Non-compliance with the Regulation Lactobacillus casei DG 2010;8(2):1470, rebalancing of intestinal because on the basis of the scientific CNCM I-1572 and 2012;10(6):2723 microflora;- rebalances evidence assessed, this claimed effect decreasing potentially the intestinal motility for this food has not been pathogenic gastrofunction;- supports the substantiated. intestinal maintenance of microorganisms intestinal homeostasis;promotes the wellbeing of the intestine;contributes to reducing gastro-intestinal discomfort; - contributes to the Non-compliance with the Regulation L. paracasei LPC 01 2010;8(2):1470, rebalancing of intestinal because on the basis of the scientific (CNCM I-1390) and 2012;10(8):2850 microflora;- supports the evidence assessed, this claimed effect 'relieve symptoms maintenance of attributes to this food the property of typically associated intestinal homeostasis;- preventing, treating or curing a human with Irritable Bowel promotes the wellbeing disease, or refers to such properties Syndrome (IBS), of the intestine;which is prohibited for foods. especially diarrhoeacontributes to reducing predominant IBS, and gastro-intestinal to help reduce the daily discomfort;- improves number of bowel the metabolic activity of movements as well as intestinal microflora. improve the consistency of faeces in adult subjects reporting acute diarrhoea'

Non-authorised 3061 (expiry of transitional period 02/01/2014)

Non-authorised 3055 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium breve BR 03 (DSM 16604) +Lactobacillus plantarum LP 01 (LMG P-21021)

- favorisce il mantenimento dell'omeostasi intestinale; contribuisce a ridurre il discomfort gastrointestinale; - riduce la flatulenza ed il gonfiore addominale; riequilibria la funzione motoria intestinale; ottimizza il transito intestinale; - riequilibria la composizione della microflora dopo trattamento con antibiotici.

Non-compliance with the Regulation A combination of 2010;8(2):1470, because on the basis of the scientific Bifidobacterium breve 2012;10(8):2854 evidence assessed, this food is not BR03 and Lactobacillus sufficiently characterised for a plantarum LP01 related scientific assessment of this claimed to the following claimed effect and the claim could not therefore effect: 'reducing be substantiated. gastrointestinal discomfort associated with increased transit time'

Non-authorised 2938 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus LA 02 (LMG P21381)+Lactobacillus plantarum LP 01 (LMG P21021)

Art.13(1) special hydrolysed milk proteins

Art.13(1) Guar Gum

- favorisce il Non-compliance with the Regulation A combination of 2010;8(2):1470, mantenimento because on the basis of the scientific Lactobacillus 2012;10(8):2854 dell'omeostasi evidence assessed, this food is not acidophilus LA02 and intestinale; sufficiently characterised for a Lactobacillus plantarum contribuisce a ridurre il scientific assessment of this claimed LP01 related to the discomfort gastroeffect and the claim could not therefore following claimed effect: intestinale; - riduce la be substantiated. 'relief of abdominal flatulenza ed il gonfiore discomfort and pain' addominale; riequilibria la funzione motoria intestinale; ottimizza il transito intestinale; - riequilibria la composizione della microflora dopo trattamento con antibiotici. - good for your blood Non-compliance with the Regulation maintenance of normal 2009;7(9):1259 pressure - supports a because on the basis of the scientific blood pressure healthy blood pressure - evidence assessed, the evidence helps maintain a healthy provided is insufficient to substantiate blood pressure - helps this claimed effect for this food. maintain a normal blood pressure - guar gum helps you to Non-compliance with the Regulation Increase in satiety 2010;8(2):1464 feel full for longer (to because on the basis of the scientific help maintain body evidence assessed, this claimed effect weight) - guar gum for this food has not been promotes satiety substantiated.

Non-authorised 2944 (expiry of transitional period 02/01/2014)

Non-authorised

615

Non-authorised

795

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Acacia gum (gum arabic)

- gum acacia helps to reduce blood cholesterol; - gum acacia contribute to maintain a good cardiovascular health; - gum acacia helps to control blood cholesterol level. Art.13(1) cholinestabilized orthosilicic- helps improve hair acid (ch-OSA) thickness (The mineral silicon (Si) is - helps maintain hair present in water as strength and hair orthosilicic acid (OSA), ch- elasticity OSA is a stabilized and concentrated source of orthosilicic acid) Art.13(1) cholinestabilized orthosilicic- helps improve hair acid (ch-OSA) thickness (The mineral silicon (Si) is - helps maintain hair present in water as strength and hair orthosilicic acid (OSA), ch- elasticity OSA is a stabilized and concentrated source of orthosilicic acid)

Non-compliance with the Regulation maintenance of normal 2009;7(9):1251 because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

1976

Non-compliance with the Regulation contribution to normal because on the basis of the scientific formation of collagen evidence assessed, this claimed effect and connective tissue for this food has not been substantiated.

2011;9(6):2259

Non-authorised

334

Non-compliance with the Regulation contribution to normal because on the basis of the scientific formation of hair and evidence assessed, this claimed effect nails for this food has not been substantiated.

2011;9(6):2259

Non-authorised

334

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sugar-free chewing gum

Art.13(1) Cocoa flavanols

- helps inhibit the Non-compliance with the Regulation Reduction of dental 2010;8(2):1480 formation of plaque; - because on the basis of the scientific plaque helps put a stop to evidence assessed, this claimed effect plaque formation; for this food has not been works against the substantiated. formation of plaque and tartar; - helps defend against the formation of plaque - helps to keep teeth and gums in normal healthy conditions by limiting/checking/impedi ng/curbing the accumulation of plaque - helps protect you from Non-compliance with the Regulation protection of lipids from 2010;8(10):1792 free radicals; because on the basis of the scientific oxidative damage - helps promote healthy evidence assessed, this claimed effect cells by minimising free for this food has not been radicals; substantiated. - helps to promote healthy cells by neutralising free radicals. antioxidant(s).

Non-authorised

3084

Non-authorised

1506

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) cholinestabilized orthosilicic- helps reduce the Non-compliance with the Regulation Maintenance of normal 2011;9(6):2259 acid (ch-OSA) appearance of wrinkles because on the basis of the scientific appearance and (The mineral silicon (Si) is - helps improve skin evidence assessed, this claimed effect elasticity of the skin present in water as elasticity has not been linked to a function of the orthosilicic acid (OSA), chbody, as required by Article 13 of the OSA is a stabilized and Regulation. concentrated source of orthosilicic acid) Art.13(1) choline-stabilized - helps support bone Non-compliance with the Regulation maintenance of normal 2011;9(6):2259 orthosilicic acid (ch-OSA) quality by stimulating because on the basis of the scientific bone bone collagen evidence assessed, this claimed effect (The mineral silicon is - helps maintain strong for this food has not been present in water as bones substantiated. orthosilicic acid; ch-OSA is - helps maintain bone a stabilized and mineral density concentrated source of - helps maintain healthy orthosilicic acid) bones Art.13(1) choline-stabilized - helps support bone Non-compliance with the Regulation contribution to normal 2011;9(6):2259 orthosilicic acid (ch-OSA) quality by stimulating because on the basis of the scientific formation of collagen bone collagen evidence assessed, this claimed effect and connective tissue (The mineral silicon is - helps maintain strong for this food has not been present in water as bones substantiated. orthosilicic acid; ch-OSA is - helps maintain bone a stabilized and mineral density concentrated source of - helps maintain healthy orthosilicic acid) bones

Non-authorised 333 (expiry of transitional period 02/01/2014)

Non-authorised

1718

Non-authorised

1718

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Medium Chain Triglycerides (MCT)

Art.13(1) Lactobacillus paracasei i CUL08 NCIMB 30154 Lactobacillus salivarius CUL 61 Bifidobacterium adolescentis (bifidum) CUL20 NCIMB 30153 Bifidobacterium lactis CUL34 NCIMB 30172

- helps to manage body Non-compliance with the Regulation reduction in body weight, - helps to because on the basis of the scientific weight reduce body fat evidence assessed, this claimed effect particularly in for this food has not been overweight persons, - substantiated. helps to limit body fat accumulation, - helps to increase energy expenditure. - helps to support the Non-compliance with the Regulation not validated development of the because on the basis of the scientific immune system from evidence assessed, this food is not birth. sufficiently characterised for a -helps to support a scientific assessment of this claimed preferable microflora effect and the claim could not therefore balance from birth. be substantiated. -proven safe for use from birth. -helps to support the development of the immune system. -helps to support a preferable micr - polydextrose promotes Non-compliance with the Regulation changes in bowel good intestinal health; because on the basis of the scientific function -polydextose improves evidence assessed, this claimed effect bowel function and gut for this food has not been comfort; substantiated.

2011;9(6):2240

Non-authorised

643

2009;7(9):1247

Non-authorised

1095

Art.13(1) Polydextrose

2011;9(6):2256

Non-authorised

784

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Polydextrose

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

- polydextrose promotes Non-compliance with the Regulation reduction of gastro2011;9(6):2256 good intestinal health; because on the basis of the scientific intestinal discomfort -polydextose improves evidence assessed, this claimed effect bowel function and gut for this food has not been comfort; substantiated. Polydextrose - polydextrose promotes Non-compliance with the Regulation Changes in short chain 2011;9(6):2256 good intestinal health; because on the basis of the scientific fatty acid (SCFA) -polydextose improves evidence assessed, this claimed effect production and/or pH in bowel function and gut for this food is not a beneficial the gastro-intestinal comfort; physiological effect as required by the tract Regulation. Lactobacillus helveticus - probiotic Non-compliance with the Regulation Alleviation of 2009;7(9):1247, CNCM I-1722 and '-helps gastro-intestinal because on the basis of the scientific psychological stress 2012;10(8):2849 Bifidobacterium longum comfort. evidence assessed, this claimed effect CNCM I-3470 for this food has not been substantiated. Lactobacillus helveticus - probiotic Non-compliance with the Regulation A combination of 2009;7(9):1247, CNCM I-1722 and -helps gastro-intestinal because on the basis of the scientific Lactobacillus 2012;10(6):2720 Lactobacillus rhamnosus comfort/ transit. evidence assessed, this claimed effect rhamnosus CNCM ICNCM I-1720 for this food has not been 1720 and Lactobacillus substantiated. helveticus CNCM I1722 and defence against pathogenic gastro-intestinal microorganisms. Sacharomyces cerevisiae - probiotic Non-compliance with the Regulation Saccharomyces 2009;7(9):1247, var boulardii -helps maintain because on the basis of the scientific cerevisiae var. boulardii 2012;10(6):2717 intestinal flora/comfort. evidence assessed, this claimed effect CNCM I-1079 and for this food has not been defence against substantiated. pathogenic gastrointestinal microorganisms

Non-authorised

784

Non-authorised

784

Non-authorised 938 (expiry of transitional period 02/01/2014) Non-authorised 939 (expiry of transitional period 02/01/2014)

Non-authorised 913 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Propionibacterium - probiotic freudenreichii SI 41 and -is viable and active Propionibacterium during intestinal transit freudenreichii SI 26 Propio- and beneficially affects Fidus the intestinal flora by increasing bifidobacteria. Art.13(1) Lactobacillus gasseri PA - probiotic 16/8, Bifidobacterium -strenghtens the bifidum MF 20/5 and immune system; Bifidobacterium longum SP -enhances the bodys 07/3 natural defences. Art.13(1) Lactobacillus helveticus I- - probiotic 1722 '- Helps balance the intestinal flora - Helps maintain digestive health '-improves your feeling of intestinal comfort; - Maintains the balance of healthy microflora Art.13(1) Bifidobacterium animalis - probiotic ssp. lactis BB-12 and '-helps against slow Lactobacillus paracasei transit; ssp. paracasei CRL-431 -improves the gastrointestinal flora.

Non-compliance with the Regulation Increasing numbers of 2009;7(9):1247, because on the basis of the scientific gastro-intestinal 2012;10(6):2721 evidence assessed, this claimed effect microorganisms. for this food has not been substantiated.

Non-authorised 941 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Maintenance of the 2009;7(9):1247, because on the basis of the scientific upper respiratory tract 2012;10(6):2718 evidence assessed, this claimed effect defence against for this food has not been pathogens substantiated. Non-compliance with the Regulation not validated 2009;7(9):1247 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised 931 (expiry of transitional period 02/01/2014) Non-authorised 886

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

935

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium breve I3425

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Bifidobacterium bifidum I- - probiotic Non-compliance with the Regulation not validated 3426 '-helps maintain a because on the basis of the scientific healthy gut flora; evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus reuteri ATCC - probiotic Non-compliance with the Regulation natural defence 55730 '-helps to strengthen the because on the basis of the scientific natural defences; evidence assessed, this claimed effect -helps to support the for this food is not sufficiently defined natural defences; to be able to be assessed and the -helps to support the claim could not therefore be body's defences; substantiated. -helps to strengthen the body's defences. Art.13(1) Lactobacillus johnsonii - probiotic Non-compliance with the Regulation improving immune NCC 533 (La1) (Pasteur '-increases your natural because on the basis of the scientific defence against culture collection CNCM I- defences; evidence assessed, this claimed effect pathogenic gastro1225) -actively supports your for this food has not been intestinal immune system; substantiated. microorganisms -strengthens your immune defences.

- probiotic '-helps balance the intestinal flora; -helps maintain digestive health.

2009;7(9):1247

Non-authorised

871

2009;7(9):1247

Non-authorised

859

2010;8(10):1805

Non-authorised

905

2011;9(6):2231

Non-authorised

896

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Page 165

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium lactis Bi-07 - probiotic (ATCC SD5220) - helps body's natural defences; '- helps to strenghten the natural defenses;

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus paracasei - probiotic Non-compliance with the Regulation not validated Lpc-37 (ATCC SD5275) - helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '- helps to strenghten sufficiently characterised for a the natural defenses; scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus johnsonii La- - probiotic Non-compliance with the Regulation not validated 19/CLbA5 and because on the basis of the scientific Bifidobacterium animalis Biogarde/Bioghurt/Bi evidence assessed, this food is not ssp. lactis Bf-6/Bif-6/CB111garde/Bighurtsufficiently characterised for a (Biogarde/Bioghurt/Biga Cultures activate/ scientific assessment of this claimed rde/Bighurt-Cultures) stimulate the body's effect and the claim could not therefore natural (immune) be substantiated. defences.

2010;8(2):1470

Non-authorised

3008

2010;8(2):1470

Non-authorised

3007

2009;7(9):1247

Non-authorised

932

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Page 166

820

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus johnsonii La- - probiotic Non-compliance with the Regulation not validated 19/CLbA5 and because on the basis of the scientific Bifidobacterium animalis Biogarde/Bioghurt/Bi evidence assessed, this food is not ssp. lactis Bf-6/Bif-6/CB111garde/Bighurtsufficiently characterised for a (Biogarde/Bioghurt/Biga Cultures support the scientific assessment of this claimed rde/Bighurt-Cultures) natural beneficial gut effect and the claim could not therefore flora; be substantiated. Biogarde/Bioghurt/Bi garde/BighurtCultures support the natural beneficial gut flora and activate/stimulate thereby the metabolism and the natural de

2009;7(9):1247

Non-authorised

940

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Page 167

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus ATCC53103 (LGG)

- probiotic Non-compliance with the Regulation gastrointestinal health 2011;9(6):2233 -LGG acts as a part of because on the basis of the scientific the natural, beneficial evidence assessed, this claimed effect intestinal microbiota; for this food is not sufficiently defined -LGG supports to be able to be assessed and the beneficial microbiota claim could not therefore be and healthy intestinal substantiated. metabolism; -LGG supports a healthy digestive tract and mucosal barrier function; -LGG balances intestinal activity; -contains probiotics; -is a source of probiotics; -with probiotic/-s; -with (probiotic)/(name of the probiotic). Art.13(1) Lactobacillus paracasei - probiotic Non-compliance with the Regulation not validated 2009;7(9):1247 NCC 2461 (ST11) (Pasteur -ST11 helps to reinforce because on the basis of the scientific culture collection CNCM I- skin barrier function; evidence assessed, this food is not 2116) -ST11 helps to reduce sufficiently characterised for a the reactivity of skin; scientific assessment of this claimed -ST11 helps to reduce effect and the claim could not therefore the sensitivity of skin; be substantiated. -ST11 helps to preserve skin health.

Non-authorised

906

Non-authorised

899

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Page 168

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei - probiotic Non-compliance with the Regulation not validated NCC 2461 (ST11) (Pasteur -balances your intestinal because on the basis of the scientific culture collection CNCM I- flora; evidence assessed, this food is not 2116) -supports digestive sufficiently characterised for a system; scientific assessment of this claimed -improves digestive effect and the claim could not therefore comfort; be substantiated. -reduces/ relieves bloating. Art.13(1) Lactobacillus casei Lafti - probiotic Non-compliance with the Regulation not validated L26 (CBS 116.412) -enhance levels of because on the basis of the scientific beneficial microflora; evidence assessed, this food is not -balance your intestinal sufficiently characterised for a microflora; scientific assessment of this claimed -beneficially affect the effect and the claim could not therefore intestinal flora; be substantiated. -supports a balanced beneficial gastrointestinal micro flora. Art.13(1) Bifidobacterium animalis - probiotic Non-compliance with the Regulation not validated ssp. lactis BB-12, -enhances/supports because on the basis of the scientific Lactobacillus acidophilus your bodys natural evidence assessed, this food is not LA-5, Lactobacillus defence. sufficiently characterised for a delbrueki ssp. bulgaricus scientific assessment of this claimed LBY-27 and Streptococcus effect and the claim could not therefore thermophilus STY-31 be substantiated.

2009;7(9):1247

Non-authorised

895

2009;7(9):1247

Non-authorised

888

2009;7(9):1247

Non-authorised

919

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Page 169

820

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus fermentum CECT5716

- probiotic -help/ contribute/ participate in increasing the natural defenses; -help/ contribute/ participate to strengh the immune system; Art.13(1) Lactobacillus gasseri - probiotic CECT5714 and -help/ contribute/ Lactobacillus coryniformis participate in increasing CECT5711 the natural defenses; -help/ contribute/ participate to strenghen the immune system; Art.13(1) Lactobacillus plantarum - probiotic Rosell-1012 -helps balance the intestinal flora; -helps maintain digestive health.

Non-compliance with the Regulation maintenance of the 2010;8(10):1802 because on the basis of the scientific upper respiratory tract evidence assessed, this claimed effect defence against for this food has not been pathogens by substantiated. maintaining immune defences Non-compliance with the Regulation natural because on the basis of the scientific defence/immune evidence assessed, this claimed effect system for this food is not a beneficial physiological effect as required by the Regulation. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. 2010;8(10):1803

Non-authorised

916

Non-authorised

930

2009;7(9):1247

Non-authorised

901

Art.13(1) Streptococcus thermophilus I-3428

- probiotic -helps balance the intestinal flora; -helps maintain digestive health.

2009;7(9):1247

Non-authorised

914

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Page 170

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus casei I-3429 - probiotic Non-compliance with the Regulation not validated -helps balance the because on the basis of the scientific intestinal flora; evidence assessed, this food is not -helps maintain sufficiently characterised for a digestive health; scientific assessment of this claimed -contributes to the gut effect and the claim could not therefore health by increasing be substantiated. number of beneficial bacteria in the gut. Art.13(1) Bifidobacterium breve I- probiotic Non-compliance with the Regulation not validated 3425 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Bifidobacterium infantis I- - probiotic Non-compliance with the Regulation not validated 3424 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Bifidobacterium longum I- - probiotic Non-compliance with the Regulation not validated 3470 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated.

2009;7(9):1247

Non-authorised

889

2009;7(9):1247

Non-authorised

873

2009;7(9):1247

Non-authorised

876

2009;7(9):1247

Non-authorised

878

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Page 171

820

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus Lafti L10 (CBS 116.411)

- probiotic Non-compliance with the Regulation not validated -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Lactobacillus casei I-3429 - probiotic Non-compliance with the Regulation not validated -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Lactobacillus helveticus I- - probiotic Non-compliance with the Regulation not validated 1722 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Lactobacillus plantarum - probiotic Non-compliance with the Regulation not validated Rosell-1012 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated.

2009;7(9):1247

Non-authorised

883

2009;7(9):1247

Non-authorised

891

2009;7(9):1247

Non-authorised

887

2009;7(9):1247

Non-authorised

903

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Page 172

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus I- - probiotic Non-compliance with the Regulation not validated 1720 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Streptococcus - probiotic Non-compliance with the Regulation not validated thermophilus I-3428 -helps body's natural because on the basis of the scientific defences; evidence assessed, this food is not '-helps to strenghten the sufficiently characterised for a natural defenses; scientific assessment of this claimed '-helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Lactobacillus gasseri PA - probiotic Non-compliance with the Regulation not validated 16/8 and Bifidobacterium -helps to maintain a because on the basis of the scientific bifidum MF 20/5 healthy gut flora; evidence assessed, this food is not -beneficial for sufficiently characterised for a maintaining a healthy scientific assessment of this claimed intestinal flora; effect and the claim could not therefore '-contributes to a be substantiated. healthy digestive system by supporting a well-balanced gut flora through an increased number of beneficial bacteria in the gut.

2009;7(9):1247

Non-authorised

911

2009;7(9):1247

Non-authorised

915

2009;7(9):1247

Non-authorised

936

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Page 173

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium animalis ssp. lactis BB-12 and Lactobacillus acidophilus LA-5

- probiotic Non-compliance with the Regulation not validated -helps to support your because on the basis of the scientific natural defences; evidence assessed, this food is not -helps to strenghten the sufficiently characterised for a natural defense; scientific assessment of this claimed -helps to stimulate the effect and the claim could not therefore immune system be substantiated. Art.13(1) Bifidobacterium animalis - probiotic Non-compliance with the Regulation not validated ssp. lactis BB-12 and -improves the microflora because on the basis of the scientific Lactobacillus acidophilus in elderly; evidence assessed, this food is not LA-5 -beneficially affects the sufficiently characterised for a microflora; scientific assessment of this claimed -helps to keep your effect and the claim could not therefore digestive system in be substantiated. balance; -helps maintain a healthy digestive system; -helps maintain a healthy gut flora. Art.13(1) Lactobacillus paracasei - probiotic Non-compliance with the Regulation not validated NCC 2461 (ST11) (Pasteur -increases your natural because on the basis of the scientific culture collection CNCM I- defences; evidence assessed, this food is not 2116) -actively supports your sufficiently characterised for a immune system; scientific assessment of this claimed -strengthens your effect and the claim could not therefore immune defences; be substantiated. Art.13(1) Bifidobacterium animalis - probiotic Non-compliance with the Regulation Immune defence ssp. lactis BB-12 -support your natural because on the basis of the scientific against pathogens defences; evidence assessed, this claimed effect -strenghten the natural for this food has not been defense. substantiated.

2009;7(9):1247

Non-authorised

870

2009;7(9):1247

Non-authorised

868

2009;7(9):1247

Non-authorised

897

2011;9(4):2047

Non-authorised

863

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Page 174

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus I- - probiotic; -beneficialy 1720 affects the intestinal flora; -supports a healthy intestinal flora.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Bifidobacterium - produces folic acid Non-compliance with the Regulation not validated adolescentis EI-3 -MB 239 and riboflavin;- supports because on the basis of the scientific (DSM 18350) the maintenance of evidence assessed, this food is not intestinal homeostasis;- sufficiently characterised for a contributes to the scientific assessment of this claimed rebalancing of intestinal effect and the claim could not therefore microflora;- promotes be substantiated. the wellbeing of the intestine. Art.13(1) Bifidobacterium - produces folic acid Non-compliance with the Regulation not validated pseudocatenulatum EI-20 -and riboflavin;- supports because on the basis of the scientific MB 116 (DSM 18353) the maintenance of evidence assessed, this food is not intestinal homeostasis;- sufficiently characterised for a contributes to the scientific assessment of this claimed rebalancing of intestinal effect and the claim could not therefore microflora;- promotes be substantiated. the wellbeing of the intestine.

2009;7(9):1247

Non-authorised

907

2010;8(2):1470

Non-authorised

3036

2010;8(2):1470

Non-authorised

3038

Generated on: 28/01/2014 09:37 AM

Page 175

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum LP - produces folic acid Non-compliance with the Regulation A combination of 2010;8(2):1470, 01(LMG Pand riboflavin;- supports because on the basis of the scientific Bifidobacterium 2012;10(8):2854 21021)+Lactobacillus the maintenance of evidence assessed, this food is not animalis subsp. lactis plantarum LP 02(LMG P- intestinal homeostasis;- sufficiently characterised for a BS01, Lactobacillus 21020)+Lactobacillus contributes to the scientific assessment of this claimed rhamnosus LR04, rhamnosus LR 04(DSM rebalancing of intestinal effect and the claim could not therefore Lactobacillus 16605) +Lactobacillus microflora;- promotes be substantiated. rhamnosus LR05, rhamnosus LR 05(DSM the wellbeing of the Lactobacillus plantarum 19739) +Bifidobacterium intestine. LP01, Lactobacillus lactis BS 01(LMG P-21384) plantarum LP02 and short-chain fructooligosaccharides or galactooligosaccharides related to the following claimed effect: 'defence against upper respiratory tract infections' Art.13(1) Bifidobacterium - produces folic acid;- Non-compliance with the Regulation not validated 2010;8(2):1470 adolescentis EI-18 -MB supports the because on the basis of the scientific 227-BA05 (DSM 18352) maintenance of evidence assessed, this food is not intestinal homeostasis;- sufficiently characterised for a promotes the wellbeing scientific assessment of this claimed of the intestine. effect and the claim could not therefore be substantiated.

Non-authorised 3047 (expiry of transitional period 02/01/2014)

Non-authorised

3037

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Page 176

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei subsp. paracasei CRL 1289

Art.13(1) Lactobacillus crispatus CRL 1251

- produces high Non-compliance with the Regulation not validated quantities hydrogen because on the basis of the scientific peroxide that protects evidence assessed, this food is not oropharyngeal cavity sufficiently characterised for a from harmful scientific assessment of this claimed microrganisms;- helps effect and the claim could not therefore to restore and maintain be substantiated. normal vaginal microflora;- assists the direct defensive response against harmful microrganisms;inhibits the - produces high Non-compliance with the Regulation not validated quantities hydrogen because on the basis of the scientific peroxide that protects evidence assessed, this food is not oropharyngeal cavity sufficiently characterised for a from harmful scientific assessment of this claimed microrganisms; - helps effect and the claim could not therefore to restore and maintain be substantiated. normal vaginal microflora; - assists the direct defensive response against harmful microrganisms ; - inhibits the g

2010;8(2):1470

Non-authorised

3046

2010;8(2):1470

Non-authorised

3044

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Page 177

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri CRL - produces metabolites Non-compliance with the Regulation not validated 1259 (acidophilus group) that protect the because on the basis of the scientific oropharyngeal cavity evidence assessed, this food is not from harmful sufficiently characterised for a microrganisms; - helps scientific assessment of this claimed to restore and maintain effect and the claim could not therefore normal vaginal be substantiated. microflora; - assists in the direct defensive response against harmful microrganisms, in particular gramnegative germs Art.13(1) Lactobacillus fermentum LF- produces natural Non-compliance with the Regulation not validated 11(DSM 19188) substances that protect because on the basis of the scientific the intestine from evidence assessed, this food is not harmful yeasts, in sufficiently characterised for a particular those of the scientific assessment of this claimed Candida type;effect and the claim could not therefore supports the be substantiated. maintenance of intestinal homeostasis;contributes to restoring the natural barrier effect of the intestinal

2010;8(2):1470

Non-authorised

3043

2010;8(2):1470

Non-authorised

3041

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Page 178

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus fermentum LF- produces natural Non-compliance with the Regulation not validated 10 (DSM 19187) substances that protect because on the basis of the scientific the intestine from evidence assessed, this food is not harmful yeasts, in sufficiently characterised for a particular those of the scientific assessment of this claimed Candida type;effect and the claim could not therefore supports the be substantiated. maintenance of intestinal homeostasis;contributes to restoring the natural barrier effect of the intestinal wall. Art.13(1) Lactobacillus paracasei - produces riboflavin;- Non-compliance with the Regulation not validated subsp. paracasei LPC 00 promotes the wellbeing because on the basis of the scientific (LMG P-21380) of the intestine;evidence assessed, this food is not supports the sufficiently characterised for a maintenance of scientific assessment of this claimed intestinal homeostasis. effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus paracasei - produces riboflavin;- Non-compliance with the Regulation not validated subsp. paracasei LPC promotes the wellbeing because on the basis of the scientific 00(LMG P-21380)+ of the intestine;evidence assessed, this food is not Lactobacillus rhamnosus supports the sufficiently characterised for a LR 04(DSM maintenance of scientific assessment of this claimed 16605)+Bifidobacterium intestinal homeostasis.- effect and the claim could not therefore breve BR 03 (DSM 16604) assists autochthonous be substantiated. intestinal flora in controlling episodes of diarrhoea;- rebalances the intestinal motility function, especiall

2010;8(2):1470

Non-authorised

3040

2010;8(2):1470

Non-authorised

3042

2010;8(2):1470

Non-authorised

3053

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Page 179

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei subsp. paracasei LPC 00(LMG P21380)+Lactobacillus rhamnosus LR 04(DSM 16605)+Bifidobacterium breve BR 03 (DSM 16604)

- produces riboflavin;- Non-compliance with the Regulation not validated promotes the wellbeing because on the basis of the scientific of the intestine;evidence assessed, this food is not supports the sufficiently characterised for a maintenance of scientific assessment of this claimed intestinal homeostasis.- effect and the claim could not therefore rebalances the be substantiated. composition of microflora after treatment with antibiotics;- contributes to the rebalancing of intestinal microflora;- i Art.13(1) Bifidobacterium - promotes the Non-compliance with the Regulation not validated adolescentis EI-15 -ALB 1 wellbeing of the because on the basis of the scientific (DSM 18351) intestine;- contributes to evidence assessed, this food is not restoring intestinal sufficiently characterised for a bacterial flora;scientific assessment of this claimed contributes to the effect and the claim could not therefore rebalancing of intestinal be substantiated. microflora;- improves the metabolic activity of intestinal microflora.

2010;8(2):1470

Non-authorised

3054

2010;8(2):1470

Non-authorised

3039

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Page 180

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium breve BL - promuove la funzione Non-compliance with the Regulation Bifidobacterium longum 2010;8(2):1470, 03 (DSM 16603) motoria intestinale; because on the basis of the scientific BL03 related to the 2012;10(8):2854 contribuisce al evidence assessed, this food is not following claimed effect: riequilibrio della sufficiently characterised for a 'intestinal mobility' microflora intestinale; - scientific assessment of this claimed favorisce il effect and the claim could not therefore mantenimento be substantiated. dell'omeostasi intestinale; - ottimizza il transito intestinale nell'anziano. Art.13(1) Bifidobacterium - rebalances the Non-compliance with the Regulation Bifidobacterium 2010;8(2):1470, adolescentis BA 02 (DSM intestinal motility because on the basis of the scientific adolescentis BA02 2012;10(8):2854 17103) function; -contributes to evidence assessed, this food is not related to the following the rebalancing of sufficiently characterised for a claimed effect: intestinal microflora; - scientific assessment of this claimed 'intestinal motility' supports the effect and the claim could not therefore maintenance of be substantiated. intestinal homeostasis; promotes the wellbeing of the intestine; restores intestinal flora bacteria in the elderly; optimizes intestinal transit in the elderly.

Non-authorised 2937 (expiry of transitional period 02/01/2014)

Non-authorised 3035 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum LP - rebalances the 01(LMG Pintestinal motility 21021)+Bifidobacteriumadofunction;- contributes to lescentis EI-18 -MB 227- reducing gastroBA05(DSM 18352) intestinal discomfort;reduces flatulence and abdominal bloating;contributes to restoring intestinal bacterial flora; - optimizes intestinal transit in the elderly;produces Art.13(1) Lactobacillus plantarum LP - rebalances the 01(LMG P-21021)+ intestinal motility Bifidobacterium lactis BS function;- rebalances 01(LMG P-21384) the composition of microflora after treatment with antibiotics;- improves the metabolic activity of intestinal microflora; promotes the wellbeing of the intestine.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3049

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3051

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Page 182

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum LP - rebalances the 01(LMG Pintestinal motility 21021)+Bifidobacterium function;- rebalances adolescentis EI-18 -MB the intestinal motility 227-BA05(DSM 18352) function in children;contributes to reducing gastro-intestinal discomfort;- contributes to reducing gastrointestinal discomfort in children;- reduces flatulence and ab Art.13(1) Lactobacillus plantarum LP - rebalances the 01(LMG Pintestinal motility 21021)+Bifidobacterium function;- rebalances lactis BS 01(LMG P-21384)the intestinal motility function in children;rebalances the composition of microflora after treatment with antibiotics;- rebalances the composition of microflora after treatment with antibio

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3050

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3052

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium breve BR - riequilibria la funzione Non-compliance with the Regulation Bifidobacterium breve 2010;8(2):1470, 03 (DSM 16604) motoria intestinale; because on the basis of the scientific BR03 related to the 2012;10(8):2854 contribuisce al evidence assessed, this food is not following claimed effect: riequilibrio della sufficiently characterised for a 'intestinal mobility' microflora intestinale; ; - scientific assessment of this claimed migliora l'attivit effect and the claim could not therefore metabolica della be substantiated. microflora ; intestinale; ; - ottimizza il transito intestinale nell'anziano. Art.13(1) Lactobacillus plantarum LP- riequilibria la funzione Non-compliance with the Regulation Lactobacillus plantarum 2010;8(2):1470, 01 (LMG P-21021) motoria intestinale; because on the basis of the scientific LP01 related to the 2012;10(8):2854 contribuisce a ridurre il evidence assessed, this food is not following claimed effect: discomfort gastrosufficiently characterised for a 'intestinal mobility' intestinale; - riduce la scientific assessment of this claimed flatulenza ed il gonfiore effect and the claim could not therefore addominale; be substantiated. contribuisce a reintegrare la flora batterica intestinale; ottimizza il transito intestinale nell'anziano.

Non-authorised 2936 (expiry of transitional period 02/01/2014)

Non-authorised 2965 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium lactis BS 01 (LMG P-21384)

- riequilibria la funzione Non-compliance with the Regulation B. animalis subsp. 2010;8(2):1470, motoria intestinale; because on the basis of the scientific lactis LMG P-21384 2012;10(8):2851 riequilibria la evidence assessed, this claimed effect and changes in bowel composizione della for this food has not been function microflora dopo substantiated. trattamento con antibiotici; - migliora l'attivit metabolica della microflora intestinale; - promuove il benessere dell'intestino. Art.13(1) Bifidobacterium lactis BS - supporta le naturali Non-compliance with the Regulation A combination of 2010;8(2):1470, 01 (LMG Pdifese dell'organismo; - because on the basis of the scientific Bifidobacterium 2012;10(8):2854 21384)+Lactobacillus rinforza le difese evidence assessed, this food is not animalis subsp. lactis rhamnosus LR 04 (DSM naturali; - contribuisce sufficiently characterised for a BS01, Lactobacillus 16605)+Lactobacillus al mantenimento del scientific assessment of this claimed rhamnosus LR04, plantarum LP 02(LMG P- benessere intestinale; - effect and the claim could not therefore Lactobacillus plantarum 21020) favorisce il be substantiated. LP02, and short-chain mantenimento fructo-oligosaccharides dell'omeostasi related to the following intestinale; - reintegra la claimed effect: 'defence flora batterica against upper intestinale. respiratory tract infections'

Non-authorised 2940 (expiry of transitional period 02/01/2014)

Non-authorised 2941 (expiry of transitional period 02/01/2014)

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

- supports concentration Non-compliance with the Regulation increased attention 2011;9(6):2225 and mental because on the basis of the scientific performance under evidence assessed, this claimed effect conditions of mental or for this food has not been physical exertion substantiated. - helps to maintain working memory and brain performance in aging adults Art.13(1) Glutamine - supports concentration Non-compliance with the Regulation improvement of working 2011;9(6):2225 and mental because on the basis of the scientific memory performance under evidence assessed, this claimed effect conditions of mental or for this food has not been physical exertion substantiated. - helps to maintain working memory and brain performance in aging adults Art.13(1) Bifidobacterium breve BR - supports the Non-compliance with the Regulation not validated 2010;8(2):1470 03 (DSM 16604) + maintenance of because on the basis of the scientific Lactobacillus plantarum LP intestinal homeostasis;- evidence assessed, this food is not 01 (LMG P-21021) supports the sufficiently characterised for a maintenance of scientific assessment of this claimed intestinal homeostasis effect and the claim could not therefore in children;be substantiated. contributes to reducing gastro-intestinal discomfort;- contributes to reducing gastrointestinal discomfort in children;- reduces f

Non-authorised

1570

Non-authorised

1570

Non-authorised

3058

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus LA 02 (LMG P21381)+Lactobacillus plantarum LP 01 (LMG P21021)

- supports the maintenance of intestinal homeostasis;supports the maintenance of intestinal homeostasis in children;contributes to reducing gastro-intestinal discomfort;- contributes to reducing gastrointestinal discomfort in children;- reduces f Art.13(1) Streptococcus - supports the natural thermophilus FP4(DSM defences of the 18616) +Lactobacillus organism;- strengthens acidophilus LA 02 (LMG P- natural defences. 21381)+Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606)+Lactobacillus rhamnosus LR 04 (DSM 16605)

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3060

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3057

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium lactis BS 01 (LMG P21384)+Lactobacillus rhamnosus LR 04 (DSM 16605)+ Lactobacillus plantarum LP 02(LMG P21020)+Lactoferrin

Non-compliance with the Regulation A combination of 2010;8(2):1470, because on the basis of the scientific Bifidobacterium 2012;10(8):2854 evidence assessed, this food is not animalis subsp. lactis sufficiently characterised for a BS01, Lactobacillus scientific assessment of this claimed rhamnosus LR04, effect and the claim could not therefore Lactobacillus plantarum be substantiated. LP02, lactoferrin and short-chain fructooligosaccharides related to the following claimed effect: 'defence against upper respiratory tract infections' Art.13(1) Lactobacillus plantarum LP - supports the natural Non-compliance with the Regulation not validated 2010;8(2):1470 01(LMG Pdefences of the because on the basis of the scientific 21021)+Lactobacillus organism;- supports the evidence assessed, this food is not plantarum LP 02(LMG P- natural defences of sufficiently characterised for a 21020)+Lactobacillus children;- strengthens scientific assessment of this claimed rhamnosus LR 04(DSM natural defences;effect and the claim could not therefore 16605) +Lactobacillus strengthens natural be substantiated. rhamnosus LR 05(DSM defences of children;19739) +Bifidobacterium contributes to the lactis BS 01(LMG P-21384)maintenance of intestinal wellbeing;contributes to the maintenance

- supports the natural defences of the organism;- strengthens natural defences;contributes to the maintenance of intestinal wellbeing;promotes the maintenance of intestinal homeostasis;restores intestinal bacterial flora.

Non-authorised 3059 (expiry of transitional period 02/01/2014)

Non-authorised

3048

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sugar-free chewing gum with Xylitol

- works against the Non-compliance with the Regulation Reduction of dental formation of plaque and because on the basis of the scientific plaque tartar; evidence assessed, this claimed effect - keep plaque at bay; for this food has not been - helps counter the substantiated. plaque formation thereby keeping teeth and gums in normal healthy conditions; - works against plaque Art.13(1) Essential fatty acid -Alpha-linolenic acid Non-compliance with the Regulation Molecule precursors Alpha-linolenic acid (LNA - (omega 3) is important because on the basis of the scientific regulating cell omega 3) for the immune system; evidence assessed, this claimed effect functions - Alpha-linolenic acid for this food is not sufficiently defined (omega 3) helps to to be able to be assessed and the maintain normal healthy claim could not therefore be blood lipid levels which substantiated. is important for the immune system / which helps support the body's immune system Art.13(1) Molybdenum -Antioxidant. Non-compliance with the Regulation Protection of DNA, -Protects cells from because on the basis of the scientific proteins and lipids from ageing. evidence assessed, this claimed effect oxidative damage -Important for nitrogen for this food has not been metabolism. substantiated. Art.13(1) Alpha-cyclodextrin (a -Attenuates the rise in Non-compliance with the Regulation Reduction of postsoluble dietary fiber) blood glucose / insulin because on the basis of the scientific prandial glycaemic after a meal evidence assessed, the evidence responses -Moderates the blood provided is insufficient to substantiate glucose/insulin this claimed effect for this food. response to a meal

2011;9(6):2266

Non-authorised

3085

2011;9(4):2050

Non-authorised

492

2010;8(10):1745

Non-authorised

341

2010;8(2):1479

Non-authorised

856

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Art.13(1) Wheat Dextrin

-Diet rich in fiber can help you maintain good cardiovascular health. -Dietary fiber helps maintain healthy cholesterol levels to promote overall heart health. -Dietary fiber helps maintain healthy blood pressure to promote overall heart health. -Diets rich in fiber can help promote healthy triglyceride levels -Diet rich in fiber can help you maintain good cardiovascular health. -Dietary fiber helps maintain healthy cholesterol levels to promote overall heart health. -Dietary fiber helps maintain healthy blood pressure to promote overall heart health. -Diets rich in fiber can help promote healthy triglyceride levels

Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 because on the basis of the scientific (fasting) blood evidence assessed, this claimed effect concentrations of for this food has not been triglycerides substantiated.

Non-authorised

1682

Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

1682

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Art.13(1) Caffeine

-Diet rich in fiber can help you maintain good cardiovascular health. -Dietary fiber helps maintain healthy cholesterol levels to promote overall heart health. -Dietary fiber helps maintain healthy blood pressure to promote overall heart health. -Diets rich in fiber can help promote healthy triglyceride levels -Enhances physical performance. -Provides a performance edge -Can delay the onset of fatigue -Can increase exercise intensity/work rate

Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 because on the basis of the scientific blood pressure evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1682

Non-compliance with the Regulation Increase in physical because on the basis of the scientific performance during evidence assessed, this claimed effect short-term highfor this food has not been intensity exercise substantiated.

2011;9(4):2053

Non-authorised

1489

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Galacto-oligosaccharides -GOS stimulates the Non-compliance with the Regulation Decreasing potentially 2011;9(4):2060 growth of Bifidobacteria because on the basis of the scientific pathogenic gastroin the colon; evidence assessed, this claimed effect intestinal -GOS beneficially for this food has not been microorganisms affects the intestinal substantiated. flora; -GOS are prebiotics/bifidogenic; -GOS improve healthy intestinal condition. Art.13(1) Glucosamine -Glucosamine (and Non-compliance with the Regulation Maintenance of joints 2009;7(9):1264 chondroitin) may help to because on the basis of the scientific maintain healthy joints - evidence assessed, this claimed effect Glucosamine (and for this food has not been chondroitin) helps substantiated. support healthy knees

Non-authorised

765

Non-authorised 1562 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucosamine

-Glucosamine alone or Non-compliance with the Regulation Maintenance of joints in combination with because on the basis of the scientific chondroitin sulphate evidence assessed, this claimed effect contributes to the for this food has not been maintenance of substantiated. flexibility and mobility of the joints -helps to maintain healthy joint supports mobility -helps to keep joints supple and flexible -necessary for the structure of cartilage and other connective tissues -is produced naturally by the body where it plays a role in the smooth working of the joints -is produced naturally by the body where it helps maintain connective tissues -helps maintain healthy joints, bones, ligaments and tendons occurs naturally in the joints and muscles where it plays a role in the smooth working of connective tissue -helps maintain joint health helps keep joints in good condition/ --helps

2009;7(9):1264

Non-authorised 1561 (expiry of transitional period 02/01/2014)

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EFSA opinion reference Commission regulation

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Entry Id

maintain cartilage"", ""helps rebuilding cartilage"" and ""lays down the foundation for everyday rebuilding of connective tissues around the joints, including tendons, ligaments and cartilage Art.13(1) Glucosamine sulfate -Glucosamine sulfate Non-compliance with the Regulation reduction of possesses because on the basis of the scientific inflammation antiinflammatory activity evidence assessed, this claimed effect -Helps the bodys for this food has not been antiinflammatory substantiated. defenses -Reverses pro -inflammatory effects -Is a useful antiinflammatory -Is a potent anti-inflammatory -Down-regulates the catabolic effects of proinflammatory molecules Art.13(1) Glucosamine (Glucosamine-Helps maintain joint Non-compliance with the Regulation Maintenance of joints HCl or Glucosamine health. -Helps maintain because on the basis of the scientific sulphate) healthy and flexible evidence assessed, this claimed effect joints. for this food has not been substantiated. Art.13(1) Glucosamine (Glucosamine-Helps maintain joint Non-compliance with the Regulation Maintenance of joints HCl or Glucosamine health. -Helps maintain because on the basis of the scientific sulphate) and Chondroitin healthy and flexible evidence assessed, this claimed effect sulphate joints. for this food has not been substantiated.

2009;7(9):1264

Non-authorised

1869

2009;7(9):1264

Non-authorised 1563 (expiry of transitional period 02/01/2014) Non-authorised 1564 (expiry of transitional period 02/01/2014)

2009;7(9):1264

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Status

Entry Id

Art.13(1) Taurine

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation contribution to normal because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated. Alpha-cyclodextrin -Helps to control/reduce Non-compliance with the Regulation Maintenance or (a soluble dietary fiber) body fat mass; -helps to because on the basis of the scientific achievement of a control blood fat levels evidence assessed, this claimed effect normal body weight and body fat storage for this food has not been substantiated. Emblica officinalis -Helps to promote Non-compliance with the Regulation protection of DNA, (common name : Amla) healthy ageing because on the basis of the scientific proteins and lipids from -Helps to protect from evidence assessed, this claimed effect oxidative damage oxidative cell /DNA for this food has not been damage substantiated. Emblica officinalis -Helps to promote Non-compliance with the Regulation protection of cells from (common name : Amla) healthy ageing because on the basis of the scientific premature aging -Helps to protect from evidence assessed, this claimed effect oxidative cell /DNA for this food is not sufficiently defined damage to be able to be assessed and the claim could not therefore be substantiated. Saccharomyces boulardii -Helps to reinforce the Non-compliance with the Regulation Saccharomyces ATY-SB-101 natural defenses; because on the basis of the scientific boulardii ATY-SB-101 -Stimulates the immune evidence assessed, this food is not (BCCM/MUCL 53837) system; sufficiently characterised for a related to the following scientific assessment of this claimed claimed effects: effect and the claim could not therefore ""modulating both be substantiated. innate and adaptive host immunity to respond against pathogen infection""

-Helps physical and mental performance in cases of temporary stress

2011;9(4):2035

Non-authorised

1659

2010;8(2):1479

Non-authorised

2925

2010;8(10):1752

Non-authorised

4329

2010;8(10):1752

Non-authorised

4329

2009;7(9):1247, 2012;10(6):2722

Non-authorised 1011 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucomannan (Konjac)

Art.13(1) Milk fat globule membrane/Milk phospholipids

-Helps to restore / Non-compliance with the Regulation maintenance of normal 2010;8(10):1798 promote / regulate because on the basis of the scientific bowel function normal intestinal evidence assessed, this claimed effect function - Facilitates the for this food has not been intestinal transit substantiated. promotes regularity of the bowel/colonic function -Helps to maintain normal bowel/colonic function Ensures a healthy digestive system /function -Helps to Non-compliance with the Regulation immune 2010;8(10):1799 support/strengthen the because on the basis of the scientific function/immune natural defence evidence assessed, this claimed effect system -Helps to for this food is not sufficiently defined support/strengthen the to be able to be assessed and the body's defences claim could not therefore be substantiated.

Non-authorised

1557

Non-authorised

645, 1743

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Inulin / FOS (2 ->1 linked -Inulin (or FOS) Non-compliance with the Regulation not validated 2011;9(6):2244 fructans) promotes healthy gut because on the basis of the scientific bacteria or microflora; evidence assessed, this food is not -Inulin (or FOS) is a sufficiently characterised for a prebiotic; scientific assessment of this claimed -Inulin (or FOS) is effect and the claim could not therefore bifidogenic; be substantiated. -Inulin (or FOS) promotes good digestive health; -Inulin (or FOS) promotes gastrointestinal /bowel/gut/colonic health; - Prebiotics Art.13(1) Essential fatty acid -Linoleic acid (omega 6) Non-compliance with the Regulation molecule precursors 2011;9(6):2235 Linolenic Acid (LA-omega is important for healthy because on the basis of the scientific regulating cell functions 6) vascular function and evidence assessed, this claimed effect (prostaglandines, the immune system. for this food is not sufficiently defined leucotrienes) to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

767

Non-authorised

4670

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Essential fatty acid -Linoleic acid (omega 6) Non-compliance with the Regulation molecule precursors 2011;9(6):2235 Linoleic Acid (LA - omega is important for the because on the basis of the scientific regulating cell functions 6) immune system; evidence assessed, this claimed effect (prostaglandines, - Linoleic acid (omega for this food is not sufficiently defined leucotrienes) 6) helps to maintain to be able to be assessed and the normal healthy blood claim could not therefore be lipid levels which is substantiated. important for the immune system/ which helps support the body's immune system Art.13(1) Saccharomyces boulardii -Maintains intestinal Non-compliance with the Regulation Saccharomyces 2009;7(9):1247, ATY-SB-101 microflora's balance; because on the basis of the scientific boulardii ATY-SB-101 2012;10(6):2722 - probiotic evidence assessed, this food is not (BCCM/MUCL 53837) -regulates your sufficiently characterised for a related to the following intestinal transit; scientific assessment of this claimed claimed effects: -balances your intestinal effect and the claim could not therefore ""maintains and flora; be substantiated. restores the natural -supports healthy flora"" digestive system. Art.13(1) Bifidobacterium animalis -Probiotic. Non-compliance with the Regulation Decreasing potentially 2011;9(4):2047 ssp. lactis BB-12 -Contributes to a because on the basis of the scientific pathogenic gastrohealthy level of natural evidence assessed, this claimed effect intestinal good bacteria in your for this food has not been microorganisms body, which can aid substantiated. digestion. -Supports a healthy digstive system. -Beneficially affects the intestinal flora.

Non-authorised

488

Non-authorised 1010 (expiry of transitional period 02/01/2014)

Non-authorised

866

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Entry Id

Art.13(1) Beverages low / free of energy

Art.13(1) Rye bread

-Product x is energy free / low in energy.. to help take care of your body shape/take care of your silhouette. -Product X, an ally to your weight management programme. Product X is an energy free beverage that can help control your weight. -Stimulates insulin secretion. -Low insulin response.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

1147

Art.13(1) Sugar beet fibre

Non-compliance with the Regulation not validated 2011;9(4):2082 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. -Sugar beet fibre helps Non-compliance with the Regulation maintenance of normal 2011;9(4):2034 to maintain healthy because on the basis of the scientific blood LDL-cholesterol cholesterol levels evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

1179

Non-authorised

809

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

-Wheat dextrin has low Non-compliance with the Regulation reduction of post2010;8(10):1761 glycemic and because on the basis of the scientific prandial glycaemic insulinemic indices. evidence assessed, this claimed effect responses -Eating a diet high in for this food has not been fiber can help control substantiated. postprandial glucose levels and serum lipid profiles. -Dietary fiber helps improve glycemic control to improve your ability to maintain normal blood sugar and insulin levels, essential for good health. Art.13(1) Carbohydrates with a low -a low GI [carbohydrate] Non-compliance with the Regulation not validated 2010;8(2):1491 glycaemic index (GI) diet helps to maintain because on the basis of the scientific healthy cholesterol evidence assessed, this food is not levels. sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Acacia gum (gum arabic) -acacia gum is a Non-compliance with the Regulation Decreasing potentially 2011;9(4):2022 bifidogenic fibre; because on the basis of the scientific pathogenic gastro-acacia gum has a evidence assessed, this claimed effect intestinal prebiotic effect; for this food has not been microorganisms -acacia gum stimulates substantiated. the growth of beneficial bacteria in the colon; -acacia gum beneficially modulates the intestinal flora.

Non-authorised

3096

Non-authorised

481

Non-authorised

758

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Acacia gum (gum arabic)

Art.13(1) Acacia gum (gum arabic)

Art.13(1) Acacia gum (gum arabic)

-acacia gum promotes good intestinal health;acacia gum improves bowel functions & gut comfort; -acacia gum promotes good intestinal health;acacia gum improves bowel functions & gut comfort; -acacia gum promotes good intestinal health;acacia gum improves bowel functions & gut comfort;

Art.13(1) PROPOLIS

Art.13(1) Protein

Non-compliance with the Regulation Changes in bowel because on the basis of the scientific function evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation Reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation Changes in short chain because on the basis of the scientific fatty acid (SCFA) evidence assessed, this claimed effect production and pH in for this food is not a beneficial the gastro-intestinal physiological effect as required by the tract Regulation. -contributes to ease Non-compliance with the Regulation not validated throat discomfort because on the basis of the scientific - helps to soften the evidence assessed, this food is not throat sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. -foods/ meals/ diets rich Non-compliance with the Regulation contribution to the in protein help you feel because on the basis of the scientific maintenance or fuller for longer to help evidence assessed, this claimed effect achievement of a manage your weight; for this food has not been normal body weight -protein promotes substantiated. satiety.

2011;9(4):2022

Non-authorised

759

2011;9(4):2022

Non-authorised

759

2011;9(4):2022

Non-authorised

759

2010;8(10):1810

Non-authorised

1246

2010;8(10):1811

Non-authorised

414

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Protein

-foods/ meals/ diets rich Non-compliance with the Regulation increase in satiety 2010;8(10):1811 in protein help you feel because on the basis of the scientific leading to a reduction in fuller for longer to help evidence assessed, this claimed effect energy intake manage your weight; for this food has not been -protein promotes substantiated. satiety. Art.13(1) Fructoligosaccharides from -fructoligosaccharides Non-compliance with the Regulation decreasing potentially 2011;9(4):2023 sucrose from sucrose / because on the basis of the scientific pathogenic gastrooligofructose stimulates evidence assessed, this claimed effect intestinal the growth of for this food has not been microorganisms Bifidobacteria in the substantiated. colon; -fructoligosaccharides/ oligofructose beneficially affects the intestinal flora; -fructoligosaccharides/ oligofructose are prebiotics; -fructoligosaccharides/ oligofructose promote healthy/good/balanced gut bacteria.

Non-authorised

414

Non-authorised

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Art.13(1) Fructoligosaccharides from -fructoligosaccharides Non-compliance with the Regulation Changes in bowel sucrose from sucrose/ because on the basis of the scientific function oligrofructose promote evidence assessed, this claimed effect healthy conditions in the for this food has not been colon; substantiated. -fructoligosaccharides/ oligrofructose improve bowel function; -fructoligosaccharides/ oligrofructose improve gut comfort. Art.13(1) Fructoligosaccharides from -fructoligosaccharides Non-compliance with the Regulation Reduction of gastrosucrose from sucrose/ because on the basis of the scientific intestinal discomfort oligrofructose promote evidence assessed, this claimed effect healthy conditions in the for this food has not been colon; substantiated. -fructoligosaccharides/ oligrofructose improve bowel function; -fructoligosaccharides/ oligrofructose improve gut comfort.

2011;9(4):2023

Non-authorised

775

2011;9(4):2023

Non-authorised

775

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructoligosaccharides from -fructoligosaccharides Non-compliance with the Regulation changes in short chain 2011;9(4):2023 sucrose from sucrose/ because on the basis of the scientific fatty acid (SCFA) oligrofructose promote evidence assessed, this claimed effect production and pH in healthy conditions in the for this food is not a beneficial the gastro-intestinal colon; physiological effect as required by the tract -fructoligosaccharides/ Regulation. oligrofructose improve bowel function; -fructoligosaccharides/ oligrofructose improve gut comfort. Art.13(1) Fructoligosaccharides from -fructooligosaccharides/ Non-compliance with the Regulation increasing calcium 2011;9(4):2023 sucrose oligrofructose enhance/ because on the basis of the scientific and/or magnesium promote/ increase evidence assessed, this claimed effect absorption leading to magnesium absorption; for this food has not been an increase in -fructooligosaccharides/ substantiated. magnesium and/or oligrofructose enhance/ calcium retention promote/ increase calcium absorption; -fructooligosaccharides/ oligrofructose support isoflavone activity on bone health

Non-authorised

775

Non-authorised

776

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Entry Id

Art.13(1) Fruits (fresh, frozen, canned, bottled, dried, juiced)

Art.13(1) L-Theanine

Art.13(1) Unsaturated fats/fatty acids

-fruit protects the bodys Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 cells; because on the basis of the scientific proteins and lipids from -protects you from free evidence assessed, this claimed effect oxidative damage radicals; for this food has not been -protects your cells and substantiated. tissues from oxidation; -antioxidants help strengthen our body's natural defences against oxidative stress. -help relaxation without Non-compliance with the Regulation alleviation of 2011;9(6):2238 drowsiness. because on the basis of the scientific psychological stress -Stress relief. evidence assessed, this claimed effect -Physical stress relief. for this food has not been -Relax from fatigue. substantiated. -Support relation for optimal mental and physical well-being. -help to maintain the Non-compliance with the Regulation function of the cell 2011;9(6):2220 function and fluidity of because on the basis of the scientific membrane the cellular menbranes. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

1211

Non-authorised

1598

Non-authorised

622

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Status

Entry Id

Art.13(1) L-Theanine

-help to maintained a Non-compliance with the Regulation reduction of menstrual 2011;9(6):2238 calm and relaxed because on the basis of the scientific discomfort physical and evidence assessed, this claimed effect psychological state pre- for this food has not been menstrual period. substantiated. -support in premenstrual syndrome. Support a normal healthy attitude during menstrual cycle. Art.13(1) 16. -helps improve oral Non-compliance with the Regulation maintenance of tooth 2011;9(6):2233 Lactobacillus rhamnosus health because on the basis of the scientific mineralisation LGG -helps maintain a evidence assessed, this claimed effect healthy oral flora for this food has not been -helps maintain oral substantiated. health -helps improve dental health Art.13(1) Lactobacillus acidophilus -helps to improve the Non-compliance with the Regulation not validated 2009;7(9):1247 CUL21 NCIMB 30156 bodys natural because on the basis of the scientific Lactobacillus acidophilus defences; evidence assessed, this food is not CUL 60 NCIMB 30157 -helps to strengthen the sufficiently characterised for a Bifibobacterium immune system; scientific assessment of this claimed adolescentis CUL 20 -helps to maintain a effect and the claim could not therefore NCIMB 30153 dominance of friendly be substantiated. Bifiidobacterium lactis bacteria particularly in (animalis ssp. lactis) CUL the elderly 34 NCIMB 30172 -helps to boost the natural defenses among the elderly.

Non-authorised

1599

Non-authorised

3018

Non-authorised

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Entry Id

Art.13(1) Lactobacillus acidophilus -helps to improve the Non-compliance with the Regulation Maintains the balance 2010;8(2):1470, bar 13 (CNCM-I-3857) and level of natural good because on the basis of the scientific of healthy microbiota 2012;10(8):2849 Bifidobacterium longum barbacteria in your body; evidence assessed, this claimed effect that helps to strengthen 33 (CNCM-I-3858)- mix 1:1 -helps to aid digestion for this food is not sufficiently defined the natural defence and well-being; to be able to be assessed and the -helps to reduce gastro- claim could not therefore be intestinal discomfort; substantiated. -maintains the balance of healthy microflora; -beneficially affects the intestinal flora; -helps to support your natural defences; -helps to strenghten the natural defense; -helps to stimulate the immune system. Art.13(1) Lactobacilus acidophilus -improves intestinal Non-compliance with the Regulation not validated 2009;7(9):1247 CUL60 environment and because on the basis of the scientific Lactobacillus casei LC11 functionality. evidence assessed, this food is not Bifidobacterium lactis -maintains healthy sufficiently characterised for a CUL34 digestive system scientific assessment of this claimed -supports good effect and the claim could not therefore digestive function be substantiated. -maintains balance of healthy microflora

Non-authorised 2942 (expiry of transitional period 02/01/2014)

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Oligofructose-enriched inulin (specific selection of short & long chains) from chicory

-increased bone mineral Non-compliance with the Regulation not validated density; because on the basis of the scientific -increased bone evidence assessed, this food is not strength. sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Table top sweeteners and -intense sweeteners Non-compliance with the Regulation maintenance of normal foods beverages containinghave no effect on because on the basis of the scientific blood glucose intense sweeteners carbohydrate evidence assessed, this claimed effect concentrations metabolism, short or for this food has not been long-term blood glucose substantiated. control or insulin secretion; -product [x] assists in blood glucose control. Art.13(1) Table top sweeteners and -intense sweetners help Non-compliance with the Regulation contribution to the foods beverages containingto maintain a healthy because on the basis of the scientific maintenance or intense sweeteners body weight; evidence assessed, this claimed effect achievement of a -intense sweetners help for this food has not been normal body weight to control calorie intake. substantiated. Art.13(1) Bifidobacterium animalis -intestinal comfort Non-compliance with the Regulation not validated ssp. lactis BB-12, - helps to support because on the basis of the scientific Lactobacillus acidophilus digestive flora evidence assessed, this food is not LA-5, Lactbacillus - helps to reduce sufficiently characterised for a bulgaricus LBY-27 and uncomfortable intestinal scientific assessment of this claimed Streptococcus disturbances effect and the claim could not therefore thermophilus STY-31 be substantiated.

2011;9(6):2244

Non-authorised

772

2011;9(6):2229

Non-authorised

1221

2011;9(6):2229

Non-authorised

1136

2010;8(2):1470

Non-authorised

4227

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Inulin/oligofructose from chicory

-inulin/oligofructose Non-compliance with the Regulation not validated from chicory improves because on the basis of the scientific intestinal conditions; evidence assessed, this food is not -inulin/oligofructose fron sufficiently characterised for a chicory promotes scientific assessment of this claimed intestinal health. effect and the claim could not therefore be substantiated. Art.13(1) Inulin / oligofructose / -inulin/oligofructose/ Non-compliance with the Regulation not validated Oligofructose-enriched oligofructose enriched because on the basis of the scientific inulin (specific selection of inulin from chicory evidence assessed, this food is not short & long chains) from stimulates the growth of sufficiently characterised for a chicory Bifidobacteria in the scientific assessment of this claimed colon; effect and the claim could not therefore -inulin/oligofructose/ be substantiated. oligofructose enriched inulin from chicory beneficially affects the intestinal flora; -inulin/oligofructose/ oligofructose enriched inulin from chicory promote healthy/balanced/good gut bacteria.

2011;9(6):2244

Non-authorised

768

2011;9(6):2244

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Art.13(1) Long chain Omega 3 fatty -long chain Omega 3 Non-compliance with the Regulation contribution to the 2010;8(10):1796 acids fatty acids are important because on the basis of the scientific normal function of the for a healthy immune evidence assessed, this claimed effect immune system by system; for this food is not a beneficial decreasing the levels of -LC n3 PUFA help physiological effect as required by the eicosanoids, reduce inflammation. Regulation. arachidonic acidderived mediators and pro-inflammatory cytokines Art.13(1) Polydextrose -prebiotic Non-compliance with the Regulation Decreasing potentially 2011;9(6):2256 - polydextrose stimulate because on the basis of the scientific pathogenic gastrothe growth of beneficial evidence assessed, this claimed effect intestinal bacteria in the gut; for this food has not been microorganisms - polydextrose substantiated. stimulates the growth of Bifidobacteria in the colon; - polydextrose stimulate the growth of Lactobaccilli bacteria in the gut; - prebiotics promote healthy/well-balanced gut flora Art.13(1) Lactobacillus gasseri -probiotic -balances Non-compliance with the Regulation decreasing potentially 2009;7(9):1238 CECT5714 and your healthy intestinal because on the basis of the scientific pathogenic intestinal Lactobacillus coryniformis flora; -improves your evidence assessed, this claimed effect microorganisms CECT5711 intestinal transit. for this food has not been substantiated.

Non-authorised

2914

Non-authorised

785

Non-authorised

937

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711

Non-compliance with the Regulation improvement of because on the basis of the scientific intestinal transit evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Inulin / oligofructose / -promotes/ supports Non-compliance with the Regulation not validated Oligofructose-enriched digestive health because on the basis of the scientific inulin (specific selection of -improves bowel evidence assessed, this food is not short & long chains) from regularity; sufficiently characterised for a chicory -improves digestive/ scientific assessment of this claimed bowel function. effect and the claim could not therefore be substantiated. Art.13(1) Soups -soups fit in a weight Non-compliance with the Regulation not validated maintenance because on the basis of the scientific programme; evidence assessed, this food is not -soups help to control sufficiently characterised for a your body weight; scientific assessment of this claimed -soups, which are low in effect and the claim could not therefore energy density and high be substantiated. in volume, are useful as part of a weight management diet; -the inclusion of soups into the daily diet are effective in weight management programmes.

-probiotic -balances your healthy intestinal flora; -improves your intestinal transit.

2009;7(9):1238

Non-authorised

937

2011;9(6):2244

Non-authorised

769

2011;9(4):2082

Non-authorised

1132

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soups

Art.13(1) Soy

-soups gives you a Non-compliance with the Regulation not validated 2011;9(4):2082 feeling of satiety; -soups because on the basis of the scientific will help to fill you up; - evidence assessed, this food is not soups can delay the sufficiently characterised for a onset of hunger; -soups scientific assessment of this claimed consumed as a starter effect and the claim could not therefore that are low in energy be substantiated. density and high in volume have an affect on satiety/ satiation. -soy offers specific Non-compliance with the Regulation protection of DNA, 2011;9(7):2264 vascular benefits; '-soy because on the basis of the scientific proteins and lipids from helps keep the arteries evidence assessed, this claimed effect oxidative damage healthy and helps keep for this food has not been a healthy heart; -soy substantiated. helps protect the body tissues and cells from oxidation oxidative damage.

Non-authorised

1133

Non-authorised

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vegetables (fresh, frozen, -vegetables help protect Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 canned, bottled, dried, the bodys cells; because on the basis of the scientific proteins and lipids from juiced) -protect you from free evidence assessed, this claimed effect oxidative damage radicals; for this food has not been -protect your cells and substantiated. tissues from oxidation; -antioxidants help strengthen our body's natural defences against oxidative stress; -people should consume a wide variety of fruits and vegetables, choosing among colours present in nature, to incorporate the various phytochemical and maximise protection; -Brassica vegetables (e.g. X) provide particular protection against oxidation. Art.13(1) Dietary fibre .Fibre helps to reduce Non-compliance with the Regulation not validated 2010;8(10):1735 fat absorption. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

1216

Non-authorised

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Oenothera biennis-eveninig.Regulates cholesterol Non-compliance with the Regulation maintenance of normal 2011;9(4):2059 primrose-seeds oil level because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Art.13(1) Gamma-linolenic acid / helps maintain healthy Non-compliance with the Regulation Maintenance of the 2011;9(4):2059 (GLA) skin / supports skin because on the basis of the scientific barrier function of the condition evidence assessed, this claimed effect skin for this food has not been substantiated.

Non-authorised

4453

Non-authorised

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Entry Id

Art.13(1) Carbohydrate foods and beverages

/ maximises glycogen stores. Carbohydrate before, during exercise improves endurance performance / perform for longer. Carbohydrate rich diets before exercise help elevate pre-exercise glycogen stores. Ingestion during exercise maintains blood glucose. Glucose is the bodys naturally preferred source of energy during intense exercise Consumption in events as short as 1 hr improves exercise performance. Endurance capacity / time to exhaustion / delays fatigue. Carbohydrate loading can delay fatigue and benefits endurance and multiple sprint sports. Energy for endurance / fuel for your muscles. Carbohydrate before

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

and after exercise extends endurance time and work output more than either alone. Glycogen Sparing. Clarification provided Enhances / maximises glycogen stores. Carbohydrate before, during exercise improves endurance performance / perform for longer. Carbohydrate rich diets before exercise help elevate pre-exercise glycogen stores. Ingestion during exercise maintains blood glucose. Glucose is the bodys naturally preferred source of energy during intense exercise Consumption in events as short as 1 hr improves exercise performance. Endurance capacity / time to exhaustion / delays fatigue Carbohydrate loading can delay fatigue and

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EFSA opinion reference Commission regulation

Status

Entry Id

benefits endurance and multiple sprint sports. Energy for endurance / fuel for your muscles. Carbohydrate before and after exercise extends endurance time and work output more than either alone Glycogen Sparing

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Fat free dairy products with 1 - Main wording Non-compliance with the Regulation not validated reduced sugars or without In French: because on the basis of the scientific added sugars - Les produits laitiers evidence assessed, this food is not 0% de matire grasse sufficiently characterised for a et teneur rduite en scientific assessment of this claimed sucres (ou sans sucres effect and the claim could not therefore ajouts) aident be substantiated. contrler le poids corporel dans le cadre dune alimentation quilibre. In English : - Fat free dairy products with reduced sugars or without added sugars help control body weight as part of a balanced diet. 2 - Other examples of wordings In French : - aide maintenir le poids corporel - aide garder la ligne - partenaire nutritionnel de votre ligne In English : - help maintain body weight - help keep your figure - nutritional partner of your figure

2011;9(6):2243

Non-authorised

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Inulin/oligofructose

1) Inulin/oligofructose Non-compliance with the Regulation not validated stimulates the growth of because on the basis of the scientific Bifidobacteria in the evidence assessed, this food is not colon; 2) Beneficially sufficiently characterised for a affects the intestinal scientific assessment of this claimed flora; (3) Prebiotics effect and the claim could not therefore promote healthy gut be substantiated. bacteria; (4) promotes a healthy bowel function; (5) Promotes better intestinal flora. A better intestinal flora supports your bodys defence system; (6) Prebiotic fibres support your natural defence

2011;9(6):2244

Non-authorised

848

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Corn Oil with a guaranteed 1- When used within a Non-compliance with the Regulation maintenance of normal 2011;9(4):2064 polyunsatured fatty acids healthy, balanced diet, because on the basis of the scientific blood LDL-cholesterol content (56% of total fatty in combination with a evidence assessed, this claimed effect concentrations acids), supplemented with healty lifestyle, corn oil for this food has not been vitamin E. with an elevated vitamin substantiated. E content and a guaranteed polyunsaturates fatty acids content contributes to the control of blood cholesterol. 2-When used within a healthy, balanced diet, in combination with a healty lifestyle, corn oil contributes to the control of blood cholesterol. 3-As a part of a healthy lifesyle, corn oil helps to maintain normal blood cholesterol level.4-As a part of a healthy lifesyle, corn oil helps to keep blood cholesterol levels under control.

Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Brewer`s Yeast

1. Activates metabolism Non-compliance with the Regulation contribution to normal and energy conversion because on the basis of the scientific energy-yielding process in the body, evidence assessed, this claimed effect metabolism promotes effective for this food has not been assimilation of nutrients. substantiated. 2. Vitamins and micronutrients are highly essential for normal body functioning

2011;9(6):2247

Non-authorised

1381

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Royal jelly

1. Acts as a general Non-compliance with the Regulation not validated body restorative because on the basis of the scientific substance evidence assessed, this food is not 2. Strengthens bodys sufficiently characterised for a resistance against scientific assessment of this claimed infections effect and the claim could not therefore 3. Royal jelly helps be substantiated. strengthen your body / strengthens the body 4. Possesses body toning and antispastic properties, strengthens bodys defence abilities and resistance against stress, promotes metabolism use during recovery and postnatal period to improve your appetite and increase the overall body tonus 5. Royal jelly improves feeling of comfort 6. Royal jelly helps improve activity of the immune system/strengthens the immune system/bodys defence system 7. A generally restorative product for the maintenance of

2011;9(4):2083

Non-authorised

1225

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Apple cider vinegar

Art.13(1) Gamma linolenic acid

bodys functions strengthens the immunity, improves the state of cardiovascular system, tones up the body, stimulates mental work capacities, increases bodys adaptation in extreme and stressful situations 1. Apple cider vinegar Non-compliance with the Regulation biotransformation of 2010;8(10):1733 has body purifying and because on the basis of the scientific xenobiotic substances healing properties 2. evidence assessed, this claimed effect Splits and eliminates for this food is not sufficiently defined harmful toxins/endto be able to be assessed and the products 3. Optimizes claim could not therefore be and balances the body substantiated. function 4. Restores the inner balance of the body 1. Beneficial affects the Non-compliance with the Regulation Maintenance of normal 2010;8(2):1477 cardiovascular system because on the basis of the scientific blood cholesterol 2. Ensures regulation of evidence assessed, this claimed effect concentrations the blood vessel tonus for this food has not been 3. Promotes substantiated. lmaintenance of vascular elasticity, heart health and normal blood pressure 4. Helps regulate blood pressure and cholesterol levels

Non-authorised

1378

Non-authorised

1771

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Gamma linolenic acid

Art.13(1) Gamma linolenic acid

1. Beneficial affects the Non-compliance with the Regulation Maintenance of normal 2010;8(2):1477 cardiovascular system because on the basis of the scientific blood pressure 2. Ensures regulation of evidence assessed, this claimed effect the blood vessel tonus for this food has not been 3. Promotes substantiated. lmaintenance of vascular elasticity, heart health and normal blood pressure 4. Helps regulate blood pressure and cholesterol levels 1. Beneficial effect on Non-compliance with the Regulation Reduction of menstrual 2011;9(4):2059 womans well-being, because on the basis of the scientific discomfort particularly during evidence assessed, this claimed effect menstruation and for this food has not been menopause substantiated. 2. Beneficially affects the overall condition during premenstrual syndrome and menstruation 3. Relieves painful menstruation 4. Helps reduce symptoms of premenstrual syndrome 5. Helps maintain/keep maximum comfort during menstruation

Non-authorised

1771

Non-authorised

1775

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Gamma linolenic acid

Art.13(1) Antler

1. Evening primrose oil Non-compliance with the Regulation Reduction of menstrual 2011;9(4):2059 in the body transforms because on the basis of the scientific discomfort into biologically active evidence assessed, this claimed effect substances for this food has not been prostaglandins, which substantiated. are essential biological regulators and participate in metabolism and hormonal regulation reducing problems associated with hormonal imbalance 2. Helps ensure healthy function of the hormonal system 3. Borage oil is precursor of prostaglandins wich are regulators associated with many of the body's metabolic function 4. Contributes to maintain healthy/normal hormonal system function 1. For cardiovascular Non-compliance with the Regulation maintenance of normal 2011;9(6):2246 health. because on the basis of the scientific cardiac function 2. Improves function of evidence assessed, this claimed effect the heart for this food has not been substantiated.

Non-authorised

1773

Non-authorised

1767

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zea mays (Maize)

Art.13(1) Glucosamine

Art.13(1) Apple cider vinegar

1. For liver and Non-compliance with the Regulation Liver health gallbladder health because on the basis of the scientific beneficially affects the evidence assessed, this claimed effect function of liver and for this food is not sufficiently defined gallbladder to be able to be assessed and the 2. A beneficial effect in claim could not therefore be case of acute condition substantiated. of chronic pancreatitis 3. Beneficially affects digestion and promotes bodys detoxification processes 1. Helps generally Non-compliance with the Regulation immune strengthen the body, because on the basis of the scientific function/immune particularly during evidence assessed, this claimed effect system intense physical and for this food is not sufficiently defined mental work to be able to be assessed and the 2. Beneficially affects claim could not therefore be the bodys immunity substantiated. 1. Helps improve Non-compliance with the Regulation Bowel motor function digestion 2. Helps because on the basis of the scientific maintain normal bowel evidence assessed, this claimed effect movement 3. for this food has not been Normalizes bowel substantiated. movement 4. Promotes intestinal activity 5. Promotes/contributes to bowel regularity

2011;9(6):2228

Non-authorised

2504

2010;8(10):1799

Non-authorised

1776

2009;7(9):1230

Non-authorised

1377

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Brewer`s Yeast

1. Helps maintain a healthy nervous system 2. Stimulates mental and physical work capacities

Art.13(1) Gamma linolenic acid

Non-compliance with the Regulation Nervous system because on the basis of the scientific function evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. 1. Helps maintain Non-compliance with the Regulation "Function of the cell functions and structure because on the basis of the scientific membrane" of the body and organ evidence assessed, this claimed effect cell membranes for this food is not sufficiently defined 2. Evening primrose oil to be able to be assessed and the contains claim could not therefore be polyunsaturated fatty substantiated. acids which are necessary for cell membranes 3. Supports the integrity and the fluidity of the cell membrane 4. Omega-6 fatty acids participate in cell growing and renewal processes 5. Being present in cell membranes they are necessary for wholesome cell structure and function

2011;9(6):2228

Non-authorised

1383

2011;9(4):2059

Non-authorised

1769

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat germ oil

Art.13(1) Wheat germ oil

Art.13(1) Wheat germ oil

1. Improves metabolism Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 2. Helps maintain because on the basis of the scientific bone functions and structure evidence assessed, this claimed effect of the body and its for this food has not been organ cell membranes substantiated. 3. Activates absorption of calcium in intestinal tract thereby increasing bone density 4. Promotes body purification and reduction of body mass 1. Improves skin Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 condition, its elasticity because on the basis of the scientific skin hydration and firmness, promotes evidence assessed, this claimed effect natural renewal of skin for this food has not been cells, normalizes skins substantiated. moisture level by moisturizing it in a natural way. 1. Increases immunity Non-compliance with the Regulation reduction of 2010;8(10):1799 2. Ensures activity of because on the basis of the scientific inflammation the immune system, evidence assessed, this claimed effect reduction of for this food is not a beneficial inflammatory reactions physiological effect as required by the Regulation.

Non-authorised

1389

Non-authorised

1390

Non-authorised

1391

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein

1. Lutein is a natural Non-compliance with the Regulation maintenance of normal 2011;9(4):2030 antioxidant which because on the basis of the scientific vision protects the skin from evidence assessed, the evidence the harmful effects of provided is insufficient to substantiate free radicals this claimed effect for this food. 2. Lutein helps protect the retina and lens from free radicals which result from UV-radiation 3. Lutein is a natural antioxidant for eyes 4.Lutein protects the eye from the harmful effects of free radicals 5. Lutein helps protect the macular pigment from the harmful UVradiation and oxygencontaining free radicals

Non-authorised

1779

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein

Art.13(1) Lecithin

1. Lutein is a natural Non-compliance with the Regulation protection of the skin antioxidant which because on the basis of the scientific from UV-induced protects the skin from evidence assessed, this claimed effect (including photothe harmful effects of for this food has not been oxidative) damage free radicals substantiated. 2. Lutein helps protect the retina and lens from free radicals which result from UV-radiation 3. Lutein is a natural antioxidant for eyes 4.Lutein protects the eye from the harmful effects of free radicals 5. Lutein helps protect the macular pigment from the harmful UVradiation and oxygencontaining free radicals 1. Necessary for normal Non-compliance with the Regulation Function of the cell growth, wholesome because on the basis of the scientific membrane mental and physical evidence assessed, this claimed effect development for this food is not sufficiently defined 2. Helps maintain to be able to be assessed and the functions and structure claim could not therefore be of the body and organ substantiated. cell membranes 3. Lecithin is found in every human cell and it participates in various vitally important processes

2011;9(4):2030

Non-authorised

1779

2011;9(6):2228

Non-authorised

1777

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) ""Dietary food for special medical purposes - oral rehydrating solution with decreased osmolarity composed according to WHO/UNICEF recommendations ORSALIT. ORSALIT is available in following versions: - ORSALIT without flavor, - ORSALIT with banana flavor

1. ORSALIT is used in Non-compliance with the Regulation Treatment of diarrhoea 2011;9(6):2228 all cases when because on the basis of the scientific and/or vomiting dehydration may occur evidence assessed, this claimed effect 2. ORSALIT is attributes to this food the property of hypoosmolar, oral preventing, treating or curing a human rehydrating solution disease, or refers to such properties composed according to which is prohibited for foods. WHO and UNICEF recommendations 3. ORSALIT helps to avoid dehydration which may occur in case of diarrhea and/or vomiting 4. ORSALIT uses mechanism of collective adsorption of water, sodium and glucose which is not damaged even during diarrhea 5. ORSALIT is used in order to supplement current losses of water and electrolytes 6. Oral rehydrating solutions are used in every situation when dehydration may occur 7. ORSALIT composition is identical to current recommendations of WHO and UNICEF

Non-authorised

3087

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

8. ORSALIT composition ensures effective rehydration during diarrhea on the contrary of usually given feezy drinks (cola), apple juice or broth 9. ORSALIT rehydrates effectively during diarrhea, on the contrary to traditional methods 10. Oral rehydration is beneficial and well tolerated due to low risk of side effects 11. ORSALIT is used in order to rehydrate 12. ORSALIT is dedicated to infants, children and adults rehydration during diarrhea and/or vomiting 13. ORSALIT is dedicated to supplement body fluids and mineral components 14. ORSALIT is used in case of disturbance of water-electrolyte balance during

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

dehydration due to diarrhea and/or vomiting Art.13(1) Olive oil and/or olive pomace oil. 1. Olive oil consumption Non-compliance with the Regulation maintenance of normal helps to maintain the because on the basis of the scientific (fasting) blood health of the evidence assessed, this claimed effect concentrations of cardiovascular system for this food has not been triglycerides substantiated. 1. Olive oil consumption Non-compliance with the Regulation maintenance of normal helps to maintain the because on the basis of the scientific blood HDL-cholesterol health of the evidence assessed, this claimed effect concentrations cardiovascular system for this food has not been substantiated. 1. Olive oil consumption Non-compliance with the Regulation maintenance of normal helps to maintain the because on the basis of the scientific blood LDL-cholesterol health of the evidence assessed, this claimed effect concentrations cardiovascular system for this food has not been substantiated. 1. Omega-6 fatty acids Non-compliance with the Regulation reduction of are essential for a because on the basis of the scientific inflammation healthy immune system evidence assessed, this claimed effect / Ensures activity of the for this food has not been immune system 2. substantiated. Helps reduce inflammatory reactions / Omega-6 fatty acids help reduce inflammation 2011;9(4):2044 Non-authorised 1316

Art.13(1) Olive oil and/or olive pomace oil.

2011;9(4):2044

Non-authorised

1316

Art.13(1) Olive oil and/or olive pomace oil.

2011;9(4):2044

Non-authorised

1316

Art.13(1) Gamma linolenic acid

2009;7(9):1234

Non-authorised

1772

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Royal jelly

Art.13(1) Royal jelly

Art.13(1) Prunus amygdalus

Art.13(1) Wheat germ oil

1. Regulates the Non-compliance with the Regulation not validated function of endocrine because on the basis of the scientific glands evidence assessed, this food is not 2. Royal jelly helps sufficiently characterised for a promote milk secretion scientific assessment of this claimed in breastfeeding effect and the claim could not therefore mothers be substantiated. 1. Royal jelly contains Non-compliance with the Regulation not validated vitamins, fatty acids and because on the basis of the scientific hormone substances evidence assessed, this food is not that promote its sufficiently characterised for a beneficial effect on skin scientific assessment of this claimed 2. Vitamins and other effect and the claim could not therefore biologically active be substantiated. substances contained in royal jelly beneficially affect the skin 1. Stimulates the libido Non-compliance with the Regulation maintenance of normal 2. Improves erection, because on the basis of the scientific erectile function contributes to the evidence assessed, this claimed effect increase of sperm for this food has not been volume and relaxes substantiated. muscles 1. Strengthens the Non-compliance with the Regulation maintenance of normal cardiovascular system because on the basis of the scientific blood pressure 2. Promotes evidence assessed, this claimed effect lmaintenance of for this food has not been vascular elasticity, heart substantiated. health and normal blood pressure 3. Ensures regulation of the blood vessel tonus

2011;9(4):2083

Non-authorised

1228

2011;9(4):2083

Non-authorised

1230

2011;9(4):2036

Non-authorised

2482

2010;8(10):1762

Non-authorised

1386

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Royal jelly

Art.13(1) Fruit-rich diet

1. Substances Non-compliance with the Regulation not validated contained in royal jelly because on the basis of the scientific help normalize evidence assessed, this food is not metabolism, improve sufficiently characterised for a appetite scientific assessment of this claimed 2. Royal jelly normalizes effect and the claim could not therefore metabolism be substantiated. 3. Royal jelly is very nourishing, it contains biologically active substances amino acids (replaceable and irreplaceable), carbohydrates, vitamins, microelements and minerals 4. Royal jelly helps improve tissue breathing A diet rich in fruit Non-compliance with the Regulation not validated promotes heart health. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2083

Non-authorised

1226

2011;9(6):2245

Non-authorised

1425

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fruit-rich diet

Art.13(1) Fruits (fresh, frozen, canned, bottled, dried, juiced)

Art.13(1) Fruit-rich diet

Art.13(1) Fruits (fresh, frozen, canned, bottled, dried, juiced)

A diet rich in fruits can Non-compliance with the Regulation not validated help to control body because on the basis of the scientific weight. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. A diet rich in fruits helps Non-compliance with the Regulation not validated to control blood glucose because on the basis of the scientific level evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. A diet rich in fruits helps Non-compliance with the Regulation not validated to control blood glucose because on the basis of the scientific level. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. A diet rich in fruits helps Non-compliance with the Regulation not validated to manage body weight because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2245

Non-authorised

1426

2011;9(6):2245

Non-authorised

1214

2011;9(6):2245

Non-authorised

1427

2011;9(6):2245

Non-authorised

1213

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Long Chain Fatty Acids (EPA/DHA)

Non-compliance with the Regulation contribution to the 2010;8(10):1796 because on the basis of the scientific normal function of the evidence assessed, this claimed effect immune system by for this food is not a beneficial decreasing the levels of physiological effect as required by the eicosanoids, Regulation. arachidonic acidderived mediators and pro-inflammatory cytokines Art.13(1) Vegetable-rich diet A diet rich in vegetables Non-compliance with the Regulation not validated 2011;9(6):2245 helps controlling blood because on the basis of the scientific glucose level. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Vegetable-rich diet A diet rich in vegetables Non-compliance with the Regulation not validated 2011;9(6):2245 helps controlling body because on the basis of the scientific weight. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Vegetables (fresh, frozen, A diet rich in vegetables Non-compliance with the Regulation not validated 2011;9(6):2245 canned, bottled, dried, helps to control blood because on the basis of the scientific juiced) glucose level. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

A diet rich in long chain fatty acids may help normal immune system function.

Non-authorised

520

Non-authorised

1430

Non-authorised

1429

Non-authorised

1219

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vegetables (fresh, frozen, A diet rich in vegetables Non-compliance with the Regulation not validated canned, bottled, dried, helps to manage body because on the basis of the scientific juiced) weight. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Vegetables (fresh, frozen, A diet rich in vegetables Non-compliance with the Regulation not validated canned, bottled, dried, promotes heart health. because on the basis of the scientific juiced) evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Apium graveolens (Celery) A generally restorative Non-compliance with the Regulation "invigoration of the tea which is rich in because on the basis of the scientific body" vitamins, minerals, evidence assessed, this claimed effect antioxidants and for this food is not sufficiently defined essential herbal oils and to be able to be assessed and the helps the body claim could not therefore be overcome stress and substantiated. exertion, prevents setting in of changes associated with age, improves the immunity Art.13(1) Carbohydrates with a low A low GL diet helps to Non-compliance with the Regulation not validated glycaemic load maintain a healthy because on the basis of the scientific weight evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2245

Non-authorised

1218

2011;9(6):2245

Non-authorised

1217

2010;8(10):1738

Non-authorised

2393

2011;9(4):2082

Non-authorised

479

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrates with a low A low GL diet helps to glycaemic load maintain healthy cholesterol levels

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Carbohydrates with a low A low GL diet sustains Non-compliance with the Regulation not validated glycaemic load steady blood sugar because on the basis of the scientific levels evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Soy lecithin A natural help to control Non-compliance with the Regulation maintenance of normal blood cholesterol. because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Art.13(1) Rich in dietary fibre A nutritionally balanced Non-compliance with the Regulation not validated diet high in dietary fibre because on the basis of the scientific is important for evidence assessed, this food is not maintaining bowel sufficiently characterised for a regularity. scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2082

Non-authorised

477

2011;9(4):2082

Non-authorised

476

2010;8(10):1741

Non-authorised

1308

2010;8(10):1735

Non-authorised

1415

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Olive Biophenols

A potent source of biophenols with strong anti-bacterial properties Description of food in termsOlive biophenols are of food legislation effective in combating categories: Food bacterial infections supplement

Non-compliance with the Regulation decreasing potentially 2009;7(9):1245 because on the basis of the scientific pathogenic intestinal evidence assessed, this claimed effect microorganisms for this food has not been substantiated.

Non-authorised

1877

Was food on Irish market before 1st July 2007: No Art.13(1) Rutin

Art.13(1) Alpha Lipoic acid (ALA)

Art.13(1) Alpha-lipoic-acid

A strong antioxidant that Non-compliance with the Regulation protection of DNA, 2010;8(10):1751 protects the bodys cells because on the basis of the scientific proteins and lipids from from the harmful effects evidence assessed, this claimed effect oxidative damage of free radicals; for this food has not been Improves the immune substantiated. system. ALA might protect the Non-compliance with the Regulation Protection of body lipids 2010;8(2):1474 lipids from oxidative because on the basis of the scientific from oxidative damage damage, might also evidence assessed, this claimed effect helps to keep normal for this food has not been level of blood substantiated. cholesterol, has positive effects in fat burning. ALA might protect the Non-compliance with the Regulation Increased beta2010;8(2):1474 lipids from oxidative because on the basis of the scientific oxidation of fatty acids damage, might also evidence assessed, this claimed effect helps to keep normal for this food has not been level of blood substantiated. cholesterol, has positive effects in fat burning.

Non-authorised

1784

Non-authorised

3134

Non-authorised

3134

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Alpha-lipoic-acid

Art.13(1) Ribose

ALA might protect the Non-compliance with the Regulation Maintenance of normal 2010;8(2):1474 lipids from oxidative because on the basis of the scientific blood cholesterol damage, might also evidence assessed, this claimed effect concentrations helps to keep normal for this food has not been level of blood substantiated. cholesterol, has positive effects in fat burning. ATP is used for energy Non-compliance with the Regulation faster recovery from 2011;9(6):2257 by muscle cells. Ribose because on the basis of the scientific muscle fatigue after helps regenerate evidence assessed, this claimed effect exercise muscle ATP levels, for this food has not been thereby improving substantiated. exercise performance and recovery Ribose helps maintain cellular energy Ribose enhances recovery after strenuous activity Ribose is an important building block for cellular energy

Non-authorised

3134

Non-authorised

4226

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Casein protein hydrolysate Accelerates recovery Non-compliance with the Regulation increase in endurance 2011;9(6):2213 from exercise because on the basis of the scientific performance helps to recover faster evidence assessed, this claimed effect shortens the time to for this food has not been recover completely substantiated. helps to enhance endurance performance helps to perform longer supports endurance performance increases endurance performance increases time to fatigue during exercise helps to enhance physical performance helps to perform better supports physical performance helps to increase physical performance protects muscle during exercise

Non-authorised

1497

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Casein protein hydrolysate Accelerates recovery Non-compliance with the Regulation faster recovery from from exercise because on the basis of the scientific muscle fatigue after helps to recover faster evidence assessed, this claimed effect exercise shortens the time to for this food has not been recover completely substantiated. helps to enhance endurance performance helps to perform longer supports endurance performance increases endurance performance increases time to fatigue during exercise helps to enhance physical performance helps to perform better supports physical performance helps to increase physical performance protects muscle during exercise

2011;9(6):2213

Non-authorised

1497

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Acerola

Art.13(1) Acerola

Acerola is a major Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 dietary source of because on the basis of the scientific proteins and lipids from antioxidants evidence assessed, this claimed effect oxidative damage Antioxidants from for this food has not been dietary sources substantiated. contribute to the protection against free radicals which cause cell damage Contributes to the protection of cells and tissues from oxidative damage Help strengthen our bod Acerola is a major Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 dietary source of because on the basis of the scientific proteins and lipids from antioxidants/ evidence assessed, this claimed effect oxidative damage Antioxidants from for this food has not been dietary sources substantiated. contribute to the protection against free radicals which cause cell oxidation/ Contributes to the protection of cells and tissues from oxidation/ Help strengthen our body's natural defences against oxidative stress

Non-authorised

1256

Non-authorised

2193

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Acetyl-l-carnitine

Art.13(1) Arginine

Art.13(1) Dry isoflavones soya extract

Art.13(1) Vitamine B3

Art.13(1) Vitamine B3

Acetyl-l-carnitine helps Non-compliance with the Regulation contribution to normal to support and maintain because on the basis of the scientific cognitive function healthy brain function. evidence assessed, this claimed effect for this food has not been substantiated. Acide amin rgulateur Non-compliance with the Regulation Systme nerveux du cortisol, mdiateur because on the basis of the scientific du stress. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Act on hair bulb in order Non-compliance with the Regulation contribution to normal to support hair growth. because on the basis of the scientific hair growth Prevent hair from evidence assessed, this claimed effect premature ageing via for this food has not been their antioxidant substantiated. properties and on the microcirculation Activate the scalp Non-compliance with the Regulation maintenance of hair microcirculation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Activate the scalp Non-compliance with the Regulation maintenance of nails microcirculation because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2200

Non-authorised

1432

2011;9(4):2051

Non-authorised

608

2011;9(7):2264

Non-authorised

4254

2009;7(9):1224

Non-authorised

2875

2009;7(9):1224

Non-authorised

2875

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Horseradish root (Armoracia rusticana) ;;

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Active ingredients of Non-compliance with the Regulation relief in case of irritation 2011;9(6):2248 horseradish can support because on the basis of the scientific in the upper respiratory the respiratory system evidence assessed, this claimed effect tract health. for this food has not been substantiated. Lemon (Citrus limonium) - Acts as a natural Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 flavonodes antioxidant. Helps to because on the basis of the scientific proteins and lipids from reduce oxidative stress. evidence assessed, this claimed effect oxidative damage Helps to reduce aging for this food has not been effects. Necessary for substantiated. cells protection. Improves the antioxidant defensive system. Vitamin C Acts as free radical Non-compliance with the Regulation maintenance of vision 2009;7(9):1226 scavenger. Renders because on the basis of the scientific free radicals harmless evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food. Methylsulfonylmethane/MS Acts as natural sulfar Non-compliance with the Regulation contribution to normal 2010;8(10):1746 M source; Feeds the skin because on the basis of the scientific collagen formation from inside out; For evidence assessed, this claimed effect healthy skin, nails and for this food has not been hair; Supports a healthy substantiated. skin. Methylsulfonylmethane/MS Acts as natural sulfar Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 M source; Feeds the skin because on the basis of the scientific hair from inside out; For evidence assessed, this claimed effect healthy skin, nails and for this food has not been hair; Supports a healthy substantiated. skin.

Non-authorised

2380

Non-authorised

3183

Non-authorised

141

Non-authorised

1741

Non-authorised

1741

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Methylsulfonylmethane/MS Acts as natural sulfar Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 M source; Feeds the skin because on the basis of the scientific nails from inside out; For evidence assessed, this claimed effect healthy skin, nails and for this food has not been hair; Supports a healthy substantiated. skin. Art.13(1) Herbal yeast plasmolycate Adds vigour and Non-compliance with the Regulation not validated 2011;9(6):2243 (saccharomyces activity. because on the basis of the scientific cerevisiae) Reduces feeling of evidence assessed, this food is not tiredness. sufficiently characterised for a Improves concentration scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) N-acetyl-l-cystene Adequate supply Non-compliance with the Regulation contribution to the 2010;8(10):1795 contributes to because on the basis of the scientific normal glutathione glutathione homeostasis evidence assessed, this claimed effect formation /restoring glutathione for this food has not been levels with cysteine substantiated. helps to keep the redox state in balance /building glutathione levels with cysteine support the bodys natural defense system /building glutathione levels with cysteine supports the detoxification function of your liver

Non-authorised

1741

Non-authorised

1816

Non-authorised

1745

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-carnosine

Against skin ageing. Protects cells from ageing

Art.13(1) Chitosane

Non-compliance with the Regulation skin because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Aide combattre les Non-compliance with the Regulation reduction in body excs de poids because on the basis of the scientific weight Aide dans le cadre d'un evidence assessed, this claimed effect rgime amincissant for this food has not been Soutient lors substantiated. d'amincissement Clarification provided Contributes to management of weight control/can help in the reduction of body weight/can help to the control of weight by reducing the quantity of fat absorbed from the diet.

2011;9(4):2038

Non-authorised

1825

2011;9(6):2214

Non-authorised

679

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PROPOLIS

Art.13(1) Conjugated linoleic acid (CLA)

Aide combattre les refroidissements Aide renforcer les dfenses naturelles Soutient le systme de dfense Clarification provided Helps to maintain the integrity of the body thanks to its antimicrobial effects/Propolis has a natural antimicrobial action Aids slimming by reducing body fat and preserving lean muscle Helps to reduce muscle protein loss during a diet

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1810

Non-authorised

1245

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2010;8(10):1794

Non-authorised

686

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Conjugated linoleic acid (CLA)

Aids slimming by Non-compliance with the Regulation contribution to the reducing body fat and because on the basis of the scientific maintenance or preserving lean muscle evidence assessed, this claimed effect achievement of a Helps to reduce muscle for this food has not been normal body weight protein loss during a substantiated. diet Increases lean tissue mass Increases feelings of fullness and satiety Helps to reduce yoyoeffect after a diet Improves the burning of fat Art.13(1) Sugar-free chewing gum Aiuta a contrastare la Non-compliance with the Regulation reduction of calculus containing Pirofosfati formazione del tartaro because on the basis of the scientific formation Gomma da masticare difendendo il benessere evidence assessed, this claimed effect senza zucchero con delle gengive. Ostacola for this food has not been pirofosfati (E450i,ii,iii,iv,v) e la formazione del substantiated. tripolifosfati (E451) tartaro. Protezione denti e gengive. Clarification provided Helps to contrast formation of calculus/tartar defending the wellness of gums- Opposes calculus/tartar formation -Protection for teeth and gums

2010;8(10):1794

Non-authorised

1516

2011;9(6):2268

Non-authorised

1309

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri P 18137

Aiuta a mantenere la Non-compliance with the Regulation Defence against normale microflora because on the basis of the scientific vaginal pathogens vaginale. Aiuta a evidence assessed, this claimed effect mantenere il pH for this food has not been vaginale a livelli substantiated. fisiologici (pH acido). Ripristina l' ecosistema vaginale, alteratosi in seguito a terapia antibiotica/antimicotica. Contribuisce ad inibire lo sviluppo di microrganismi patogeni Art.13(1) Lactobacillus plantarum P Aiuta a mantenere la Non-compliance with the Regulation Defence against 17630 normale microflora because on the basis of the scientific vaginal pathogens vaginale. Aiuta a evidence assessed, this claimed effect mantenere il pH for this food has not been vaginale a livelli substantiated. fisiologici (pH acido). Ripristina l' ecosistema vaginale, alteratosi in seguito a terapia antibiotica/antimicotica. Contribuisce ad inibire lo sviluppo di microrganismi patogeni.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2957 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2967 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus crispatus P 17631

Art.13(1) Lactobacillus paracasei I1687

Aiuta a mantenere la normale microflora vaginale. Aiuta a mantenere il pH vaginale a livelli fisiologici (pH acido). Ripristina l' ecosistema vaginale, alteratosi in seguito a terapia antibiotica/antimicotica. Contribuisce ad inibire lo sviluppo di microrganismi. Aiuta a rinforzare le difese naturali. Aiuta a modulare la risposta immunitaria. Riequilibra la risposta immunitaria nei soggetti sensibili a reazioni allergiche. Coadiuva la risposta immunitaria anche nei casi di infezione virale.

Non-compliance with the Regulation Defence against because on the basis of the scientific vaginal pathogens evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2950 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Increasing IL-10 because on the basis of the scientific production and/or evidence assessed, this claimed effect enhancing the activity for this food has not been of natural killer cells substantiated.

2010;8(2):1470, 2012;10(8):2858

Non-authorised 2960 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus salivarius I1794

Art.13(1) Lactobacillus paracasei I1688

Art.13(1) Alpha lipoic acid

Art.13(1) Alpha lipoic acid

Aiuta a rinforzare le Non-compliance with the Regulation Increasing IL-10 difese naturali. Aiuta a because on the basis of the scientific production and/or modulare la risposta evidence assessed, this claimed effect enhancing the activity immunitaria. Riequilibra for this food has not been of natural killer cells la risposta immunitaria substantiated. nei soggetti sensibili a reazioni allergiche. Coadiuva la risposta immunitaria anche nei casi di infezione virale. Aiuta a rinforzare le Non-compliance with the Regulation Increasing IL-10 difese naturali.Aiuta a because on the basis of the scientific production and/or modulare la risposta evidence assessed, this claimed effect enhancing the activity immunitaria.Aiuta a for this food has not been of natural killer cells regolare la risposta substantiated. immunitaria nei soggetti che potrebbero manifestare reazioni infiammatorie. Alpha lipoc acid is Non-compliance with the Regulation increase in insulin suitable for diabetics, because on the basis of the scientific sensitivity people with impaired evidence assessed, this claimed effect glucose tolerance for this food has not been substantiated. Alpha lipoic acid helps Non-compliance with the Regulation protection of the nerve to protect the nervous because on the basis of the scientific system system. evidence assessed, this claimed effect attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2971 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2962 (expiry of transitional period 02/01/2014)

2011;9(6):2202

Non-authorised

3158

2011;9(6):2202

Non-authorised

3157

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Essential fatty acid Alpha-linolenic acid Linolenic Acid (LNA-omega (omega 3) is important 3) for healthy vascular function and immune system and blood clotting. Art.13(1) Taurine Amino acid that plays an important role in the immune system.

Art.13(1) EAS Phosphagen Elite

Art.13(1) Amylopectin

Amp up your workout with EAS Phosphagen Elite, clinically shown to improve ventilatory and lactate thresholds for greater cardiorespiratory endurance in intense workouts (training) EAS Phosphagen Elite is clinically shown to improve ventilatory and lactate thresholds Amylopectin facilitates the replenishment of glycogen stores in skeletal muscle

Non-compliance with the Regulation Molecule precursors 2011;9(4):2050 because on the basis of the scientific regulating cell evidence assessed, this claimed effect functions for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation "immune system 2011;9(4):2035 because on the basis of the scientific protection" evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation increase in endurance 2011;9(6):2247 because on the basis of the scientific performance evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

4671

Non-authorised

611

Non-authorised

1539

Non-compliance with the Regulation increase in endurance 2011;9(6):2247 because on the basis of the scientific performance during the evidence assessed, this claimed effect subsequent exercise for this food has not been bout after strenuous substantiated. exercise

Non-authorised

1437

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Amylopectin and Lcarnitine

Art.13(1) Argile verte

Art.13(1) Magnesium

Amylopectin plus LNon-compliance with the Regulation increase in endurance 2011;9(6):2247 carnitine facilitate the because on the basis of the scientific performance during the replenishment of evidence assessed, this claimed effect subsequent exercise glycogen stores in for this food has not been bout after strenuous skeletal muscle, and the substantiated. exercise switching from carbohydrate oxidation to fat oxidation. Amliore le confort Non-compliance with the Regulation not validated 2011;9(6):2244 digestif. because on the basis of the scientific Participe l'absorption evidence assessed, this food is not des toxines et des gaz sufficiently characterised for a se formant. scientific assessment of this claimed au cours du processus effect and the claim could not therefore de digestion be substantiated. Contribue au confort digestif. An adequate Non-compliance with the Regulation Maintenance of normal 2010;8(10):1807 magnesium intake can because on the basis of the scientific blood pressure support to maintain evidence assessed, the evidence normal blood pressure provided is insufficient to substantiate this claimed effect for this food.

Non-authorised

1438

Non-authorised

347

Non-authorised

366

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zeaxanthin

An optimal intake of Non-compliance with the Regulation maintenance of normal 2010;8(10):1724 zeaxanthin contributes because on the basis of the scientific vision to eye health evidence assessed, this claimed effect supports normal vision for this food has not been absorbs blue light and substantiated. scavenges reactive oxygen species in the eye (lens, retina) and, therefore, helps to maintain a healthy retina stabilizes membranes and, therefore, contributes to make retinal membranes more resistant against damage by light (together with Lutein) is actively accumulated in the healthy macula. The highest concentration of carotenoids found in the human body. A sufficient supply therefore contributes to maintaining the integrity and health of this part of the retina which is most essential for optimal visual performance. Das Carotinoid

Non-authorised

1684

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Zeaxanthin kommt in hoher Konzentration im menschlichen Auge vor. Dort schtzt es dieses vor oxidativen Schdigungen durch Radikale. Zeaxanthin ist ein Beitrag zum Schutz der Augengesundheit. Zeaxanthin ist ein Radikalfnger. wird (zusammen mit Lutein) aktiv in der gesunden Makula angereichert, die die hchste Konzentration an Carotinoiden im menschlichen Krper aufweist. Eine ausreichende Versorgung hilft, diesen Teil der Retina, der fr ein optimales Sehvermgen sehr wichtig Zeaxanthin ist ein wichtiges antioxidativ zellschtzender vitaminhnlicher Lebensmittelinhaltsstoff fr den Menschen mit

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Claim

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EFSA opinion reference Commission regulation

Status

Entry Id

besonderer Bedeutung fr den Lichtschutz. Als vergleichsweise schwaches Antioxidans kann Zeaxanthin durch die strkeren antioxidativen Nhrstoffe bzw. krpereigenen Antioxidantien z. B. die Thiole Glutathion, Cystein und Liponsure - teilweise gegen Oxidation geschtzt werden. Umgekehrt gibt es Hinweise, dass eine hohe Zufuhr von Carotinoiden wie Zeaxanthin auch einen positiven Einfluss auf den Status bei den anderen krpereigenen Antioxidantien hat. Hohe Mengen an Zeaxanthin sollten aus theoretischen Erwgungen wegen der erforderlichen Regeneration durch die krpereigenen antioxidativen

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EFSA opinion reference Commission regulation

Status

Entry Id

Schutzsysteme zusammen mit anderen antioxidativen Nhrstoffen supplementiert werden. Das gilt insbesondere fr Personen mit erfahrungsgem schlechtem antioxidativem Status (z. B. Raucher, Diabetiker). Zeaxanthin ist ein effizienter Fnger von freien Radikalen. Nach der antioxidativen Rangordnung der Carotinoide wird Zeaxanthin im Auge erst nach Vitamin E, Carorin, Lycopin und Lutein verbraucht.Zeaxanthin ist fr das Auge wahrscheinlich die letzte Sicherung gegen oxidative Schden. Die natrlich besonders hohe Konzentration von Zeaxanthin in der Netzhautmitte (dem Ort des schrfsten Sehens)

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Claim

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EFSA opinion reference Commission regulation

Status

Entry Id

besonders wichtige Schutzfunktion beim Schutz der Sehfhigkeit. (zusammen mit Lutein) hilft es, das Sehvermgen bei trben Lichtverhltnissen zu verbessern (together with Lutein) helps to improve visual performance at dim lighting conditions absorbiert blaues Licht und fngt reaktive Sauerstoffmolekle im Auge (Linse, Netzhaut) ab und trgt so zum Erhalt einer gesunden Netzhaut bei Art.13(1) Oenothera biennis-eveninigAnti-inflammatory / Non-compliance with the Regulation Anti-inflammatory primrose-seeds oil Helpful in eczema, because on the basis of the scientific properties mastalgia. evidence assessed, this claimed effect attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods.

2011;9(4):2059

Non-authorised

4454

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Claim

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotics and Prebiotics AntiBloat Probiotic & Non-compliance with the Regulation not validated 2009;7(9):1247 as contained in the formula Prebiotic improves because on the basis of the scientific AntiBloat: digestion and intestinal evidence assessed, this food is not Bifidobacterium bifidum transit alleviating sufficiently characterised for a (CNCM I-3426), bloating from the build scientific assessment of this claimed Lactobacillus casei (CNCM up of unhealthy wastes effect and the claim could not therefore MA 64U), caused by putrefying be substantiated. Lactobacillus acidophilus pathogenic bacteria. (CNCM I-1722), Lactococcus lactis (CNCM For a comfortably flat MA67/4J), stomach Fructooligosaccharides (FOS) AntiBloat supports a healthy balance of friendl Art.13(1) Antioxidant from processed Antioxidant contained in Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 fruits and vegetables and this product contribute because on the basis of the scientific proteins and lipids from juices to the anti-oxidative evidence assessed, this claimed effect oxidative damage functions of the for this food has not been body/ensure protective substantiated. effect on the organism Art.13(1) Antioxidant from processed Antioxidant contained in Non-compliance with the Regulation antioxidant activity, 2010;8(10):1752 fruits and vegetables and this product contribute because on the basis of the scientific antioxidant content, and juices to the anti-oxidative evidence assessed, this claimed effect antioxidant properties functions of the for this food is not a beneficial body/ensure protective physiological effect as required by the effect on the organism Regulation.

Non-authorised

925

Non-authorised

1306

Non-authorised

1306

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Antioxidant from processed Antioxidant contained in Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 fruits and vegetables and this product contribute because on the basis of the scientific proteins and lipids from juices to the anti-oxidative evidence assessed, this claimed effect oxidative damage functions of the for this food has not been body/ensure protective substantiated. effect on the organism; Art.13(1) Beta Carotene Antioxidant vitamins Non-compliance with the Regulation protection of DNA, 2011;9(4):2021 and minerals act because on the basis of the scientific proteins and lipids from against ageevidence assessed, this claimed effect oxidative damage accelerating free for this food has not been radicals. substantiated. Art.13(1) PROPOLIS Antioxidants can protect Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 from free radicals and because on the basis of the scientific proteins and lipids from helps in case of foods evidence assessed, this claimed effect oxidative damage intake deficiency or for this food has not been increased amount of substantiated. nutrients. Increases the physiological resistance of the organism in case of severe ambiance conditions

Non-authorised

1439

Non-authorised

19

Non-authorised

3797

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) AMORPHOPHALLUS KONJAC KOCH

Art.13(1) Antioxidants in coffee

Antioxidants can protect Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 from free radicals and because on the basis of the scientific proteins and lipids from helps in case of foods evidence assessed, this claimed effect oxidative damage intake deficiency or for this food has not been increased amount of substantiated. nutrients. Useful to protect the skin from UV -induced oxidative damage. Helps protect against the free radicals action due to UV exposure or severe ambiance conditions Antioxidants reducing the production of oxidative cholesterol. Protection against the free radicals action due to stress, alcoholics,UV exposure or polluted ambiance conditions. Antioxidants in coffee Non-compliance with the Regulation Protection of DNA, 2011;9(4):2057 helps protect our cells because on the basis of the scientific proteins and lipids from against free radicals. evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

3216

Non-authorised

3152

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Antioxidant substance

Art.13(1) Lactobacillus plantarum 299v (DSM 9843)

Art.13(1) Citrus paradisi (Common Name : Grapefruit)

Art.13(1) Apple juice

Antioxidants protect Non-compliance with the Regulation protection of DNA, cells from the harmful/ because on the basis of the scientific proteins and lipids from damaging effects of free evidence assessed, this claimed effect oxidative damage radicals. for this food has not been Antioxidants protect substantiated. against oxidation, which causes cell damage. Contains antioxidants. Antioxidants that protect Non-compliance with the Regulation protection of DNA, your bodys cells because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Antioxidative Non-compliance with the Regulation Protection of DNA, properties/supports the because on the basis of the scientific proteins and lipids from body organs and evidence assessed, this claimed effect oxidative damage tissues in case of for this food has not been oxidative damage substantiated. Apple juice helps to Non-compliance with the Regulation protection of DNA, maintain a healthy because on the basis of the scientific proteins and lipids from cardiovascular system evidence assessed, this claimed effect oxidative damage Clarification provided for this food has not been Apple juice : substantiated. - helps to maintain a healthy cardiovascular system - plays an important antioxidative function on cardiovascular system

2010;8(10):1752

Non-authorised

1441

2011;9(4):2037

Non-authorised

1083

2010;8(2):1489

Non-authorised

2025

2010;8(10):1752

Non-authorised

1196

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Apple vinegar drink

Apple vinegar drink helps to maintain vascular health.

Art.13(1) Natural Palm Oil CarotenesAre antioxidants that protects the body's cells. Can protect you from free radicals which cause cell damage. Can protect your cells and tissues from oxidative damage. Can contribute to the total antioxidant capacity of the body. Art.13(1) Brassicaceae (Cruciferae) Are particularly rich of (Common Name : Botanicalprotective compounds family that include broccoli, that protect cells and couliflower, cabbage, DNA from oxidative Bruxelles sprouts etc.) damage/are particularly rich of compounds that help our body to eliminate toxic substances

Non-compliance with the Regulation maintenance of normal 2011;9(6):2199 because on the basis of the scientific blood pressure evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation not validated 2011;9(4):2082 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

1447

Non-authorised

1621

Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1312

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-Arginine

Art.13(1) L-Arginine

Arginine can contribute to the maintenance of the healthy blood circulation. Clarification provided Arginine can contribute to the maintenance of the healthy blood circulation. Arginine can contribute to the maintance of the normal blood circulation, such as the healthy blood pressure and the haematopoiesis. Arginine can contribute to the maintenance of the healthy blood circulation. Clarification provided Arginine can contribute to the maintenance of the healthy blood circulation. Arginine can contribute to the maintance of the normal blood circulation, such as the healthy blood pressure and the haematopoiesis.

Non-compliance with the Regulation Improvement of 2011;9(4):2051 because on the basis of the scientific endothelium-dependent evidence assessed, this claimed effect vasodilation for this food has not been substantiated.

Non-authorised

664

Non-compliance with the Regulation Maintenance of normal 2011;9(4):2051 because on the basis of the scientific blood pressure evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

664

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-Arginine

Art.13(1) Superoxide dismutase

Non-compliance with the Regulation protection of DNA, 2010;8(10):1753 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Art.13(1) Decaffeinated green As an aid to weight loss Non-compliance with the Regulation Contribution to the 2011;9(4):2057 (unroasted) coffee bean and weight control as because on the basis of the scientific maintenance or extract produced from part of a calorie evidence assessed, this claimed effect achievement of a Coffea canephora robusta controlled diet. for this food has not been normal body weight (plant:extract ratio between Acts by reducing substantiated. 6:1 to 8:1). The active absorption of sugar ingredients contained in the(glucose) from the green coffee extract are digestive tract. chlorogenic acids (>45% w/w). The chlorogenic acids main

Arginine can contribute to the maintenance of the healthy blood circulation. Clarification provided Arginine can contribute to the maintenance of the healthy blood circulation. Arginine can contribute to the maintance of the normal blood circulation, such as the healthy blood pressure and the haematopoiesis. As a strong antioxidant it protects the bodys cells from the damage caused by free radicals

Non-compliance with the Regulation Normal red blood cell because on the basis of the scientific formation evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2051

Non-authorised

664

Non-authorised

1785

Non-authorised

4326

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Mycoprotein

Art.13(1) Astaxanthin

Art.13(1) Naturligt astaxanthin frn den encelliga grnalgen Haematococcus pluvialis

Art.13(1) Naturligt astaxanthin frn den encelliga grnalgen Haematococcus pluvialis

As part of a low fat diet, Non-compliance with the Regulation maintenance of normal mycoprotein helps because on the basis of the scientific blood LDL-cholesterol maintain normal evidence assessed, this claimed effect concentrations cholesterol levels that for this food has not been keep your heart healthy substantiated. Astaxanthin favourably Non-compliance with the Regulation maintenance of joints, influence on condition of because on the basis of the scientific tendons, and cartilage. evidence assessed, this claimed effect connective tissue for this food has not been substantiated. Astaxanthin frmjar en Non-compliance with the Regulation defence against god magfunktion.#C because on the basis of the scientific Helicobacter pylori Astaxanthin improves evidence assessed, this claimed effect stomach comfort.#C for this food has not been Clarification provided substantiated. Astaxanthin improves stomach comfort.#C Astaxanthin frmjar Non-compliance with the Regulation contribution to normal spermierna/sdesceller because on the basis of the scientific spermatogenesis nas rrlighet och evidence assessed, this claimed effect funktion.#C for this food has not been Astaxanthin promotes substantiated. sperms motility and functionality.#C Clarification provided Astaxanthin promotes sperms motility and functionality.#C see MS comment.

2011;9(4):2042

Non-authorised

1619

2009;7(9):1253

Non-authorised

3142

2011;9(6):2206

Non-authorised

1686

2011;9(6):2206

Non-authorised

1688

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Naturligt astaxanthin frn den encelliga grnalgen Haematococcus pluvialis

Art.13(1) Astaxanthin

Astaxanthin ger musklerna god uthllighet och alert kropp vid trning.#C Astaxanthin maintains good muscle persistence and alert body at exercise.#C Clarification provided Astaxanthin maintains good muscle persistence and alert body at exercise.#C Astaxanthin helps to protect against free radicals and harmful factors of environment

Non-compliance with the Regulation contribution to normal because on the basis of the scientific muscle function evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2206

Non-authorised

1685

Non-compliance with the Regulation protection of DNA, 2009;7(9):1253 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

3141

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Naturligt astaxanthin frn den encelliga grnalgen Haematococcus pluvialis

Astaxanthin r bra fr hudens fuktighet och elasticitet samt skyddar mot UV-strlning.#A Astaxanthin promotes skin moisture and elasticity plus protect against UVirradiation.#A Clarification provided Astaxanthin promotes skin moisture and elasticity plus protect against UVirradiation.#A see MS

Non-compliance with the Regulation protection of the skin because on the basis of the scientific from UV-induced evidence assessed, this claimed effect damage for this food has not been substantiated.

2011;9(6):2206

Non-authorised

1687

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Naturligt astaxanthin frn den encelliga grnalgen Haematococcus pluvialis

Art.13(1) Fibersol-2 (a resistant dextrin, i.e. a soluble dietary fiber)

Astaxanthin r en Non-compliance with the Regulation Immune system 2011;9(6):2206 biologiskt aktiv because on the basis of the scientific antioxidant som skyddar evidence assessed, this claimed effect kroppens celler och for this food is not sufficiently defined bidrar till att frmja to be able to be assessed and the immunsystemets claim could not therefore be funktion. substantiated. Astaxanthin is strong antioxidant protecting the cells in the body and it helps to maintain the immune system. Clarification provided Astaxanthin is strong antioxidant protecting the cells in the body and it helps to maintain the immune system. Attenuates/moderates Non-compliance with the Regulation Maintenance of normal 2011;9(4):2070 the rise in blood because on the basis of the scientific (fasting) blood lipids/fats after a meal; evidence assessed, this claimed effect concentrations of helps to manage/ for this food has not been triglycerides control blood lipids/fat substantiated. levels; for people who need to control their blood lipid/fat levels.

Non-authorised

1689

Non-authorised

2927

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fibersol-2 (a resistant dextrin, i.e. a soluble dietary fiber)

Art.13(1) Lactobacillus rhamnosus

Attenuates/moderates Non-compliance with the Regulation maintenance of normal 2011;9(4):2070 the rise in blood because on the basis of the scientific blood LDL-cholesterol lipids/fats after a meal; evidence assessed, this claimed effect concentrations helps to manage/ for this food has not been control blood lipids/fat substantiated. levels; for people who need to control their blood lipid/fat levels. Attraverso il riequilibro Non-compliance with the Regulation Lactobacillus 2010;8(2):1470, della flora intestinale because on the basis of the scientific rhamnosus LR04 2012;10(8):2854 contribuisce a evidence assessed, this food is not related to the following migliorare il benessere sufficiently characterised for a claimed effect: della pelle e quindi scientific assessment of this claimed 'balancing intestinal anche la salute del effect and the claim could not therefore flora, improves skin, cuoio capellutoe dei be substantiated. scalp and hair health' capelli. . Agisce a alivello inetstinale favorendo il miglior assorbimento di tutti i componenti contenuti in Bioscalin antiforfora, migliorandio cos la loro disponibilit.

Non-authorised

2927

Non-authorised 2968 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacilli Probiotics as ABiotica promotes a Non-compliance with the Regulation not validated contained in the probiotic healthy balance of good because on the basis of the scientific formula ABiotica / Lacidofil:bacteria, thereby evidence assessed, this food is not - Lactobacillus acidophilus supporting health, sufficiently characterised for a - Lactobacillus rhamnosus digestion and immunity scientific assessment of this claimed for patients taking effect and the claim could not therefore antibiotics. be substantiated. ABiotica/Lacidofil probiotic maintains a healthy balanced intestinal microflora during and after antibiotic therapy Art.13(1) Folic Acid B-vitamins and vitamin Non-compliance with the Regulation energy-yielding C are essential for the because on the basis of the scientific metabolism energy metabolism / the evidence assessed, this claimed effect transfomation of food for this food has not been into energy substantiated. Art.13(1) Branched-chain amino BCAAs aid recovery Non-compliance with the Regulation faster recovery from acids after exercise because on the basis of the scientific muscle fatigue after evidence assessed, this claimed effect exercise for this food has not been substantiated. Art.13(1) Branched-chain amino BCAAs aid recovery Non-compliance with the Regulation growth or maintenance acids after exercise because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247

Non-authorised

926

2009;7(9):1213

Non-authorised

90

2010;8(10):1790

Non-authorised

447

2010;8(10):1790

Non-authorised

447

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Branched-chain amino acids

Art.13(1) Branched-chain amino acids

Art.13(1) Branched-chain amino acids

Art.13(1) Branched-chain amino acids

Art.13(1) Branched-chain amino acids

BCAAs aids muscle Non-compliance with the Regulation growth or maintenance recovery after exercise because on the basis of the scientific of muscle mass BCAAs reduce muscle evidence assessed, this claimed effect breakdown after for this food has not been exercise substantiated. BCAAs have an anabolic effect on protein metabolism after exercise BCAAs support muscle growth BCAAs aids muscle Non-compliance with the Regulation faster recovery from recovery after training because on the basis of the scientific muscle fatigue after evidence assessed, this claimed effect exercise for this food has not been substantiated. BCAAs aids muscle Non-compliance with the Regulation growth or maintenance recovery after training because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated. BCAAs improve mental Non-compliance with the Regulation improvement of performance after because on the basis of the scientific cognitive function after exercise evidence assessed, this claimed effect exercise for this food has not been substantiated. BCAAs increase protein Non-compliance with the Regulation growth or maintenance synthesis, a vital part of because on the basis of the scientific of muscle mass the muscle-building evidence assessed, this claimed effect process for this food has not been BCAAs support muscle substantiated. growth

2010;8(10):1790

Non-authorised

442

2010;8(10):1790

Non-authorised

448

2010;8(10):1790

Non-authorised

448

2010;8(10):1790

Non-authorised

446

2010;8(10):1790

Non-authorised

444

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Branched-chain amino acids

Art.13(1) Branched-chain amino acids

Art.13(1) Branched-chain amino acids

Art.13(1) Lactobacillus plantarum LB931 DSM 11918

BCAAs maintain an Non-compliance with the Regulation Healthy immune 2010;8(10):1790 optimised immune because on the basis of the scientific system function during training evidence assessed, this claimed effect BCAAs provide for this food is not a beneficial essential fuel for the physiological effect as required by the immune system Regulation. BCAAs reduce Non-compliance with the Regulation reduction in perceived 2010;8(10):1790 perceived exertion because on the basis of the scientific exertion during exercise during exercise evidence assessed, this claimed effect BCAAs make your for this food has not been workouts feel easier substantiated. BCAAs reduce the loss Non-compliance with the Regulation attenuation of the 2010;8(10):1790 of muscle power because on the basis of the scientific decline in muscle following high altitude evidence assessed, this claimed effect power following training for this food has not been exercise at high altitude BCAAs help you substantiated. maintain muscle power following high altitude exposure Balances and Non-compliance with the Regulation not validated 2009;7(9):1247 strengthen the bacterial because on the basis of the scientific flora in the urogenital evidence assessed, this food is not area sufficiently characterised for a Balances and scientific assessment of this claimed strengthen the bacterial effect and the claim could not therefore flora in the intestine be substantiated. Normalizes the bacterial flora in the intestine and urogenital area (Helps to) strengthen the natural defences Supports a healt

Non-authorised

449

Non-authorised

450

Non-authorised

443

Non-authorised

1063

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whole-grain

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) A combination of three Balances the gut flora. Non-compliance with the Regulation not validated probiotic ingredients; Helps to restore an because on the basis of the scientific Lactobacillus casei F19, unbalanced gut flora. evidence assessed, this food is not Bifidobacterium lactis Bb12 Supports a healthy gut sufficiently characterised for a and Lactobacillus flora. scientific assessment of this claimed acidophilus La5 Supports a healthy gut effect and the claim could not therefore flora during antibiotic be substantiated. treatment Supports a healthy gut flora during temporary disturbances eg. stress and antibiotic treatment Art.13(1) Dairy products containing Balances the gut flora. Non-compliance with the Regulation not validated the combination of three Supports a healthy gut because on the basis of the scientific probiotic ingredients; flora. evidence assessed, this food is not Lactobacillus casei F19, Support gastrointestinal sufficiently characterised for a Bifidobacterium lactis conditions during scientific assessment of this claimed Bb12, Lactobacillus antibiotic treatment effect and the claim could not therefore acidophilus La5 be substantiated.

Balances sugar metabolism.

2010;8(10):1766

Non-authorised

833

2009;7(9):1247

Non-authorised

923

2009;7(9):1247

Non-authorised

1086

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus reuteri DSM Balances the gut 17938 microflora.

Art.13(1) Probiotic strain: Balances the immune Bifidobacterium lactis W52 system (Formerly known as Bifidobacterium infantis W52)

Art.13(1) Probiotic strain: Lactobacillus casei W61

Balances the immune system

Art.13(1) Probiotic strain: Lactococcus lactis W64

Balances the immune system

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1087

2010;8(2):1470

Non-authorised

2989

2010;8(2):1470

Non-authorised

2983

2010;8(2):1470

Non-authorised

2986

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium infantis UCC35624

Balances your healthy intestinal flora by enhancing levels of beneficial or healthy bacteria Promotes a well balanced gut flora by replenishing healthy, beneficial bacteria Balm: due to its balsamic activity could help during the cool season.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

875

Art.13(1) SOIA ISOFLAVONI

Art.13(1) Banana

Banana is a major dietary source of antioxidants Antioxidants from dietary sources contribute to the protection against free radicals which cause cell damage Contributes to the protection of cells and tissues from oxidative damage Help strengthen our body's natural defences against oxidative stress

Non-compliance with the Regulation upper respiratory tract 2011;9(7):2264 because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

3589

Non-authorised

1257

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate electrolyte drinks

Before and during Non-compliance with the Regulation reduction in the rated exercise increase because on the basis of the scientific perceived endurance capacity / evidence assessed, this claimed effect exertion/effort during time to exhaustion / for this food has not been exercise delays fatigue. Provide substantiated. carbohydrate to muscles to supplement glycogen stores. Ingestion before and during exercise maintains blood glucose. Maintain skills during prolonged exercise Can help improve sprint / jump performance Gives athletes a performance edge During exercise maintains endurance performance / perform for longer. Provides carbohydrate, fluid and electrolytes to maintain hydration and enhances performance during prolonged intermittent exercise. Helps improve performance / a sprint finish at the towards the end of endurance events. Can improve performance even in

2011;9(6):2211

Non-authorised

466

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta vulgaris

Non-compliance with the Regulation biotransformation of 2010;8(10):1733 because on the basis of the scientific xenobiotic substances evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Beneficially affects the Non-compliance with the Regulation not validated 2010;8(2):1470 Lactobacillus salivarius oral ecology because on the basis of the scientific W24 evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Beneficially balances Non-compliance with the Regulation not validated 2010;8(2):1470 Bifidobacterium lactis BI-07 the intestinal immune because on the basis of the scientific (Formerly known as response evidence assessed, this food is not Bifidobacterium infantis BIsufficiently characterised for a 07) scientific assessment of this claimed effect and the claim could not therefore be substantiated.

events lasting less than 1 hour. Endurance performance becomes impaired when dehydration exceeds 2% of body mass Beneficially affects digestion and promotes bodys detoxification processes

Non-authorised

2401

Non-authorised

2978

Non-authorised

2993

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic strain: Beneficially balances Bifidobacterium lactis Bl-04 the intestinal immune (Formerly known as response Bifidobacterium lactis BL01 and Bifidobacterium longum BI-04) Art.13(1) Beta-glucan of Beta glucan from yeast Saccharomyces cerevisiae as immunomodulators Beta glucan from yeast support of natural defences

Art.13(1) Beta-glucan of Beta glucan from yeast Saccharomyces cerevisiae as immunomodulators Beta glucan from yeast support of natural defences

Non-compliance with the Regulation not validated 2010;8(2):1470 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation Immune system 2011;9(6):2228 because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation Increasing non-specific 2011;9(6):2228 because on the basis of the scientific serum IgA secretion evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

2995

Non-authorised

847

Non-authorised

1944

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta Alanine

Art.13(1) Beta Alanine

Art.13(1) Beta-alanine

Beta-alanine helps enhance total work performed in high intensity training. Beta-alanine helps support anaerobic training volume. Beta-alanine helps enhance anaerobic workout intensity and work volume in explosive training movements. Beta-alanine increases time-to-exhaustion to help keep you going longer. Delays muscle fatigue. Beta-alanine supplementation Increases muscle carnosine stores.

Non-compliance with the Regulation increase in time to because on the basis of the scientific exhaustion evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1729

Non-authorised

439

Art.13(1) Beta-alanine

Beta-alanine supplementation improves cycling performance

Non-compliance with the Regulation increase in time to because on the basis of the scientific exhaustion evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation increase in muscle because on the basis of the scientific carnosine stores evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation. Non-compliance with the Regulation increase in physical because on the basis of the scientific performance during evidence assessed, this claimed effect short-term highfor this food has not been intensity exercise substantiated.

2010;8(10):1729

Non-authorised

438

2010;8(10):1729

Non-authorised

1457

2010;8(10):1729

Non-authorised

1454

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta-alanine

Beta-alanine supplementation improves exercise performance.

Art.13(1) Beta-alanine

Art.13(1) Beta-alanine

Art.13(1) Beta-alanine

Art.13(1) Beta-alanine

Art.13(1) Beta-alanine

Non-compliance with the Regulation increase in physical because on the basis of the scientific performance during evidence assessed, this claimed effect short-term highfor this food has not been intensity exercise substantiated. Beta-alanine Non-compliance with the Regulation increase in time to supplementation because on the basis of the scientific exhaustion improves muscle work evidence assessed, this claimed effect capacity. for this food has not been substantiated. Beta-alanine Non-compliance with the Regulation increase in muscle supplementation because on the basis of the scientific carnosine stores increases carnosine evidence assessed, this claimed effect stores in fast twitch for this food is not a beneficial muscle fibres. physiological effect as required by the Regulation. Beta-alanine Non-compliance with the Regulation increase in physical supplementation because on the basis of the scientific performance during increases muscle evidence assessed, this claimed effect short-term highbuffering capacity. for this food has not been intensity exercise substantiated. Beta-alanine Non-compliance with the Regulation increase in time to supplementation because on the basis of the scientific exhaustion increases muscle evidence assessed, this claimed effect buffering capacity. for this food has not been substantiated. Beta-alanine Non-compliance with the Regulation increase in time to supplementation because on the basis of the scientific exhaustion reduces muscle fatigue. evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1729

Non-authorised

1453

2010;8(10):1729

Non-authorised

1456

2010;8(10):1729

Non-authorised

1458

2010;8(10):1729

Non-authorised

1459

2010;8(10):1729

Non-authorised

1459

2010;8(10):1729

Non-authorised

1455

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta Alanine

Art.13(1) Beta-Carotene

Art.13(1) Beta-Carotene

Beta-alanine supports Non-compliance with the Regulation increase in time to 2010;8(10):1729 ventilatory and fatigue because on the basis of the scientific exhaustion thresholds to help push evidence assessed, this claimed effect through intense training. for this food has not been substantiated. Beta-carotene helps to Non-compliance with the Regulation physiological immune 2009;7(9):1231 support immunity upon because on the basis of the scientific responses of the skin in UV-radiation (sun evidence assessed, this claimed effect relation to UV-radiation exposure) Helps to for this food has not been (sun exposure) maintain healthy substantiated. immune responses upon UV-radiation (sun exposure) Helps to maintain physiological immune responses of the skin upon UV radiation (sun exposure) Beta-carotene helps to Non-compliance with the Regulation physiological immune 2009;7(9):1231 support immunity upon because on the basis of the scientific responses of the skin in UV-radiation (sun evidence assessed, this claimed effect relation to UV-radiation exposure) Helps to for this food has not been (sun exposure) maintain healthy substantiated. immune responses upon UV-radiation (sun exposure) Helps to maintain physiological immune responses of the skin upon UV radiation (sun exposure)/

Non-authorised

437

Non-authorised

1463

Non-authorised

198

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Betalains

Betalains containing Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 foods contribute to keep because on the basis of the scientific content, and antioxidant your body healthy evidence assessed, this claimed effect properties Antioxidant containing for this food is not a beneficial foods support of healthy physiological effect as required by the ageing Antioxidants Regulation. contribute to the total antioxidant capacity of the body and may help strengthen our bodys defences Art.13(1) Betalains Betalains containing Non-compliance with the Regulation Protection of cells from 2010;8(2):1489 foods contribute to keep because on the basis of the scientific premature aging your body healthy evidence assessed, this claimed effect Antioxidant containing for this food is not sufficiently defined foods support of healthy to be able to be assessed and the ageing Antioxidants claim could not therefore be contribute to the total substantiated. antioxidant capacity of the body and may help strengthen our bodys defences Art.13(1) Carbonate/Bicarbonate as Bicarbonates/Carbonate Non-compliance with the Regulation maintenance of normal 2011;9(7):2301 salts of Ca, Mg, Na, K s help maintain acid - because on the basis of the scientific bone base balance; evidence assessed, this claimed effect Bicarbonates/Carbonate for this food has not been s help maintain strong substantiated. bones

Non-authorised

1468

Non-authorised

1468

Non-authorised

331

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Gele Royale

Art.13(1) Bifidobacterium (BB12) fortified cultured milk (Hodzeko-Amasi)

Bien-tre et quilibre Non-compliance with the Regulation not validated 2011;9(4):2083 lors de la mnopause because on the basis of the scientific A utiliser en cas de evidence assessed, this food is not symptmes sufficiently characterised for a mnopausiques scientific assessment of this claimed Attnue les effect and the claim could not therefore dsagrments lis la be substantiated. mnopause Clarification provided Helps to maintain a calm and comfortable menopause/helps women coping with the telltale signs associated with menopause, such as hot flushes, sweating, restlessness and irritability/Royal jelly is an effective dietary supplement for the improvement of quality of life in menopausal women. Bifidobacterium cultures Non-compliance with the Regulation Maintenance of normal 2011;9(4):2047 enhances natural because on the basis of the scientific blood LDL-cholesterol immune function, helps evidence assessed, this claimed effect concentrations maintain blood for this food has not been cholesterol substantiated.

Non-authorised

1328

Non-authorised

3089

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium (BB12) fortified cultured milk (Hodzeko-Amasi)

Bifidobacterium cultures Non-compliance with the Regulation Reduction of symptoms 2011;9(4):2047 enhances natural because on the basis of the scientific of inflammatory bowel immune evidence assessed, this claimed effect conditions function,reduces attributes to this food the property of symptoms of preventing, treating or curing a human inflammatory bowel disease, or refers to such properties conditions which is prohibited for foods. Art.13(1) Bifidobacterium (BB12) Bifidobacterium cultures Non-compliance with the Regulation Natural immune 2011;9(4):2047 fortified cultured milk enhances natural because on the basis of the scientific function (Hodzeko-Amasi) immune function. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Morinaga Bifidobacterium Bifidobacterium longum Non-compliance with the Regulation improvement of bowel 2011;9(4):2041 longum BB536 BB536 is a probiotic because on the basis of the scientific regularity that promotes bowel evidence assessed, this claimed effect regularity for this food has not been substantiated. Art.13(1) Morinaga Bifidobacterium Bifidobacterium longum Non-compliance with the Regulation normal resistance to 2011;9(4):2041 longum BB536 BB536 is a probiotic because on the basis of the scientific cedar pollen allergens that supports the evidence assessed, this claimed effect immune system for this food has not been Clarification provided substantiated. Bifidobacterium longum BB536 is a probiotic that supports the immune system by helping the body's natural resistance to allergens

Non-authorised

1469

Non-authorised

924

Non-authorised

3004

Non-authorised

3006

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Blackcurrant Ribes nigrum

Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 because on the basis of the scientific content, and antioxidant evidence assessed, this claimed effect properties for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Blackcurrant seed oil Blackcurrant seed oil Non-compliance with the Regulation maintenance of normal 2011;9(6):2208 (carbon dioxide extracted) increases HDL because on the basis of the scientific blood LDL-cholesterol + vitamin E. cholesterol levels. evidence assessed, this claimed effect concentrations Blackcurrant seed oil for this food has not been reduces LDL cholesterol substantiated. levels. Blackcurrant seed oil improves the HDL/LDL ratio. Blackcurrant seed oil supports cardiovascular health by regulating fat metabolism and blood pressure.

Blackcurrant is rich in the antioxidants anthocyanins Blackcurrant is rich in antioxidants

Non-authorised

2855

Non-authorised

572

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Blackcurrant seed oil Blackcurrant seed oil Non-compliance with the Regulation maintenance of normal 2011;9(6):2208 (carbon dioxide extracted) increases HDL because on the basis of the scientific blood pressure + vitamin E. cholesterol levels. evidence assessed, this claimed effect Blackcurrant seed oil for this food has not been reduces LDL cholesterol substantiated. levels. Blackcurrant seed oil improves the HDL/LDL ratio. Blackcurrant seed oil supports cardiovascular health by regulating fat metabolism and blood pressure. Art.13(1) Blackcurrant seed oil Blackcurrant seed oil Non-compliance with the Regulation Immune 2011;9(4):2061 (carbon dioxide extracted) regulates the immune because on the basis of the scientific function/immune + vitamin E. response. evidence assessed, this claimed effect system Blackcurrant seed oil for this food is not sufficiently defined maintains and supports to be able to be assessed and the the bodys normal claim could not therefore be defence system. substantiated. Art.13(1) Black Currant juice Blackcurrent juice helps Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 to : - protect cells because on the basis of the scientific proteins and lipids from against oxidative evidence assessed, this claimed effect oxidative damage damages - strengthen for this food has not been the immune system substantiated.

Non-authorised

572

Non-authorised

573

Non-authorised

1200

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Black Currant juice

Blackcurrent juice helps Non-compliance with the Regulation Maintenance of urinary 2011;9(6):2228 to: because on the basis of the scientific tract - improve the urinary evidence assessed, this claimed effect tract immune function. for this food is not sufficiently defined - support the normal to be able to be assessed and the functionning of the claim could not therefore be urinary tract. substantiated. Art.13(1) Creatine plus CarbohydrateBlend of ingredients Non-compliance with the Regulation Increase in muscle 2011;9(6):2228 (dextrose, sugar) clinically shown to help because on the basis of the scientific creatine stores enhance creatine evidence assessed, this claimed effect uptake into muscle for this food is not a beneficial University tests show physiological effect as required by the that a blend of creatine Regulation. and high-glycemic carbohydrate promotes creatine uptake and storage in muscle tissue Art.13(1) Glucosamine Bon pour les Non-compliance with the Regulation Maintenance of normal 2011;9(6):2247 articulations because on the basis of the scientific joints A utiliser pour maintenir evidence assessed, this claimed effect les articulations souples for this food has not been Efficace dans les substantiated. problmes d'inflammation et de mobilit des articulations Soulage les douleurs inflammatoires

Non-authorised

1199

Non-authorised

545

Non-authorised 678 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Boron as boric acid

Art.13(1) Boron as boric acid

Boron helps build and maintain healthy joints. Boron helps maintain the flexibility and mobility of the joints. Boron is beneficial for prostate health. Boron helps to maintain a healthy prostate

Art.13(1) Boron

Art.13(1) Boron

Non-compliance with the Regulation maintenance of joints 2009;7(9):1261 because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation Prevention or treatment 2011;9(6):2209 because on the basis of the scientific of prostate cancer evidence assessed, this claimed effect attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. Boron is important for Non-compliance with the Regulation maintenance of bone 2009;7(9):1261 the normal structure of because on the basis of the scientific bone. evidence assessed, this claimed effect for this food has not been substantiated. Boron may help Non-compliance with the Regulation maintenance of bone 2009;7(9):1261 maintain joint and bone because on the basis of the scientific health. evidence assessed, this claimed effect Boron involved in joint for this food has not been health. substantiated. Boron required for joint health. Boron required for bone health. Boron involved in bone metabolism.

Non-authorised

220

Non-authorised

221

Non-authorised

218

Non-authorised

219

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Boron

Art.13(1) Zinc

Art.13(1) Boron as boric acid

Art.13(1) Boron as boric acid

Boron may help Non-compliance with the Regulation maintenance of joints maintain joint and bone because on the basis of the scientific health. evidence assessed, this claimed effect Boron involved in joint for this food has not been health. substantiated. Boron required for joint health. Boron required for bone health. Boron involved in bone metabolism. Boron supports a Non-compliance with the Regulation thyroid function healthy thyroid function because on the basis of the scientific Boron is beneficial for evidence assessed, the evidence the thyroid function provided is insufficient to substantiate this claimed effect for this food. Boron supports a Non-compliance with the Regulation maintenance of normal healthy thyroid function. because on the basis of the scientific thyroid function Boron is beneficial for evidence assessed, this claimed effect the thyroid function. for this food has not been substantiated. Boron supports the Non-compliance with the Regulation contribution to normal brain functioning because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1261

Non-authorised

219

2009;7(9):1229

Non-authorised

308

2011;9(6):2209

Non-authorised

222

2011;9(6):2209

Non-authorised

223

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bovine colostrum

Bovine colostrum supports optimal recovery after intense exercise

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2048

Non-authorised

1476

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coenzyme Q10

Brings energy / Non-compliance with the Regulation contribution to normal Stimulates the psychical because on the basis of the scientific energy-yielding activity and improves evidence assessed, this claimed effect metabolism the capacity of the for this food has not been intellectual effort. / substantiated. Increases intracellular energetic mechanisms. / Helps in periods of convalescence. / Brings energy in periods of prolonged physical and intellectual effort, in acute or chronic fatigue. / Prevents fatigue and sustains the organism's effort in periods of stress. / Reduces the incidence of neoplasic diseases. / Interferes in all metabolic chains, activating them. / Improves the quality of the life of the persons with cardiac diseases. / Increases the resistance to effort and reduces the frequency and intensity of the cardiac ache.

2010;8(10):1793

Non-authorised

4668

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sulphoraphane Glucosinolate

Art.13(1) CLA (conjugated linoleic acid)

Art.13(1) CLA (conjugated linoleic acid)

Art.13(1) L-Theanine

Art.13(1) Caffeine

Broccoli sprouts contain Non-compliance with the Regulation Protection of DNA, SGS (Sulphoraphane because on the basis of the scientific proteins and lipids from glucosinolate) which evidence assessed, this claimed effect oxidative damage enhances anti-oxidant for this food has not been activity and boosts the substantiated. elimination of free radicals. CLA can support lean Non-compliance with the Regulation increase in lean body body mass because on the basis of the scientific mass evidence assessed, this claimed effect for this food has not been substantiated. CLA may protect Non-compliance with the Regulation protection of DNA, against free radicals because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Caffeine antogonist Non-compliance with the Regulation improvement of because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated. Caffeine can increase Non-compliance with the Regulation Increased energy resting metabolic rate. because on the basis of the scientific expenditure leading to Caffeine supports evidence assessed, this claimed effect a reduction in body thermogenesis and for this food has not been weight energy oxidation. substantiated.

2010;8(2):1489

Non-authorised

1934

2010;8(10):1794

Non-authorised

498

2010;8(10):1794

Non-authorised

1937

2011;9(6):2238

Non-authorised

1935

2011;9(4):2054

Non-authorised

1487

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Calcium

Art.13(1) Calcium

Art.13(1) Calcium

Calcium contributes to Non-compliance with the Regulation "cell membrane 2010;8(10):1725 normal functioning of because on the basis of the scientific permeability" cells. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Calcium helps manage Non-compliance with the Regulation contribution to the 2010;8(10):1725 your weight because on the basis of the scientific maintenance or Calcium contributes to evidence assessed, this claimed effect achievement of a weight control. Calcium for this food has not been normal body weight modulates energy substantiated. metabolism Calcium helps to keep a Non-compliance with the Regulation maintenance of normal 2009;7(9):1210 healthy blood pressure. because on the basis of the scientific blood pressure evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food.

Non-authorised

363

Non-authorised

228

Non-authorised

225

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Calcium in dairy products Calcium naturally Non-compliance with the Regulation contribution to the 2010;8(10):1725 present in dairy because on the basis of the scientific maintenance or products is important for evidence assessed, this claimed effect achievement of a weight management for this food has not been normal body weight Dairy calcium has been substantiated. shown to stimulate lipolysis. Consumption of dairy calcium aids weight loss. Dairy calcium modulates fat metabolism. Dairy calcium helps promote fat loss. Art.13(1) Calcium (as a citrate salt Calcium promotes a Non-compliance with the Regulation maintenance of normal 2009;7(9):1210 derived from the red healthy heart. Calcium because on the basis of the scientific blood pressure seaweed Lithothamnion maintains a healthy evidence assessed, the evidence Corallioides, Trade name heart. Calcium helps provided is insufficient to substantiate Aquamin S). build a healthy heart. this claimed effect for this food. Calcium helps promote Description of food in termsa healthy hear of food legislation categories: Food supplement

Non-authorised

229

Non-authorised

385

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Buffering salts (calcium carbonate + magnesium oxide)

Calms the stomach. In combination with the following sentence * Xylitol chewing gum for post-meal gastric acid attack. (or) * Xylitol gum with a fast and long-lasting neutralising effect on gastric acids. Chewing calms your stomach. In combination with the following sentence: * Xylitol chewing gum for post-meal gastric acid attack. (or) * Xylitol gum with a fast and long-lasting neutralising effect on gastric acids. Fast and long-lasting calming effect on your stomach. In combination with the following sentence * Xylitol chewing gum for post-meal gastric acid attack. * Calms the gastric acid

Non-compliance with the Regulation Reduction of gastric because on the basis of the scientific acid evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation.

2011;9(6):2228

Non-authorised

1795

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

attack * For gastric acid attack * Balances the gastric acids * Fast and long-lasting

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Nutrient, substance, food or food category

Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Casein protein hydrolysate Can accelerate Non-compliance with the Regulation increase in endurance 2011;9(6):2213 recovery from exercise because on the basis of the scientific performance can help to recover evidence assessed, this claimed effect faster for this food has not been can shorten the time to substantiated. recover completely can help to enhance endurance performance can help to perform longer can support endurance performance can increase;endurance performance can increase time to fatigue;during exercise can help to enhance physical;performance can help to perform better can support;physical performance can help to increase physical performance can help to reduce exercise induced muscle damage can help to reduce exercise induced muscle pain can protect muscle during exercise

Non-authorised

660

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Casein protein hydrolysate Can accelerate Non-compliance with the Regulation faster recovery from recovery from exercise because on the basis of the scientific muscle fatigue after can help to recover evidence assessed, this claimed effect exercise faster for this food has not been can shorten the time to substantiated. recover completely can help to enhance endurance performance can help to perform longer can support endurance performance can increase;endurance performance can increase time to fatigue;during exercise can help to enhance physical;performance can help to perform better can support;physical performance can help to increase physical performance can help to reduce exercise induced muscle damage can help to reduce exercise induced muscle pain can protect muscle during exercise

2011;9(6):2213

Non-authorised

660

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coenzyme Q10;ubiquinoneCan contribute to Non-compliance with the Regulation maintenance of normal maintain normal blood because on the basis of the scientific blood pressure pressure evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Tomato extract containing Can contribute to the Non-compliance with the Regulation protection of DNA, lycopene maintenance of prostate because on the basis of the scientific proteins and lipids from health; Can contribute evidence assessed, this claimed effect oxidative damage to the maintenance of for this food has not been the healthy function of substantiated. prostate. Art.13(1) Tomato extract containing Can contribute to the Non-compliance with the Regulation protection of the skin lycopene maintenance of skin because on the basis of the scientific from UV-induced health when exposed to evidence assessed, this claimed effect (including photosun.; Can help in the for this food has not been oxidative) damage maintenance of healthy substantiated. structure of the skin; Art.13(1) Lactotripeptides Can help to maintain a Non-compliance with the Regulation Maintenance of normal healthy blood because on the basis of the scientific blood pressure pressure/can contribute evidence assessed, this claimed effect to a healthy blood for this food has not been pressure substantiated. Art.13(1) Isomalto-oligosaccharides Can help friendly Non-compliance with the Regulation decreasing potentially bacteria grow in the because on the basis of the scientific pathogenic gastrocolon and digestive evidence assessed, this claimed effect intestinal system as part of a for this food has not been microorganisms healthy lifestyle substantiated.

2010;8(10):1793

Non-authorised

1911

2011;9(4):2031

Non-authorised

2374

2011;9(4):2031

Non-authorised

2373

2009;7(9):1259, 2012;10(6):2715

Non-authorised 661 (expiry of transitional period 02/01/2014) Non-authorised 799

2010;8(10):1809

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Isomalto-oligosaccharides Can help friendly bacteria grow in the colon and digestive system as part of a healthy lifestyle Art.13(1) Tomato extract containing lycopene

Art.13(1) Corn protein hydrolysate titrated at 29 % glutamine

Art.13(1) Isomalto-oligosaccharides

Art.13(1) Isomalto-oligosaccharides

Non-compliance with the Regulation Increasing the number because on the basis of the scientific of gastro-intestinal evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation. Can help in the Non-compliance with the Regulation contribution to normal maintenance of the because on the basis of the scientific cardiac function healthy function of the evidence assessed, this claimed effect cardiovascular system. for this food has not been substantiated. Can help to improve Non-compliance with the Regulation Physical performance physical performance because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Can help to keep your Non-compliance with the Regulation maintenance of normal cholesterols levels because on the basis of the scientific blood cholesterol healthy as part of a evidence assessed, this claimed effect concentrations healthy lifestyle for this food has not been substantiated. Can help to maintain a Non-compliance with the Regulation increase in the normal bowel function because on the basis of the scientific frequency of daily as part of a healthy evidence assessed, this claimed effect bowel movements lifestyle for this food has not been substantiated.

2010;8(10):1809

Non-authorised

799

2011;9(4):2031

Non-authorised

2372

2011;9(6):2228

Non-authorised

4248

2009;7(9):1257

Non-authorised

817

2010;8(10):1801

Non-authorised

800

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pyrus malus (Common Name Apple) extract powder containing polyphenols

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Anthocyanidines + Can help to normalise Non-compliance with the Regulation not validated proanthocyanidines blood fat levels. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Anthocyanidines + Can help to normalise Non-compliance with the Regulation not validated proanthocyanidines blood sugar levels because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Corn protein hydrolysate Can help to prevent the Non-compliance with the Regulation Overtraining and effort titrated at 29 % glutamine consequences of because on the basis of the scientific prevention overtraining in athletes. evidence assessed, this claimed effect Can help to prevent the for this food is not sufficiently defined outbreak of the effort to be able to be assessed and the claim could not therefore be substantiated. Cassis : Dry extract of Can help to reduce Non-compliance with the Regulation improvement of visual Ribes Nigrum fruit eyestrain. because on the basis of the scientific adaptation to the dark standardized at 7% of Can help to improve evidence assessed, this claimed effect anthocyanosides night vision. for this food has not been substantiated.

Can help to moderate the postprandial blood glucose level. Can help to decrease the blood glucose level.

2011;9(6):2243

Non-authorised

2713

2011;9(4):2083

Non-authorised

1788

2011;9(4):2083

Non-authorised

1789

2011;9(6):2228

Non-authorised

4247

2011;9(6):2204

Non-authorised

2750

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hydrolysat de protines de Can help with better Non-compliance with the Regulation alleviation of lait: milk protein resisting the stress because on the basis of the scientific psychological stress hydrolysate concentrated evidence assessed, this claimed effect with 1,7 % of alphaS1 for this food has not been decapeptide (=Lactium) substantiated. Art.13(1) Carnitine Can increase LNon-compliance with the Regulation increasing L-carnitine Carnitine levels during because on the basis of the scientific concentrations and/or pregnancy and evidence assessed, this claimed effect decreasing free fatty lactation. for this food is not a beneficial acids in blood during Can help decrease free physiological effect as required by the pregnancy fatty acids during Regulation. pregnancy. Can maintain normal LCarnitine plasma levels during pregnancy. Art.13(1) Natural Palm Oil CarotenesCan increase provitamin Non-compliance with the Regulation not validated A levels during because on the basis of the scientific pregnancy and evidence assessed, this food is not lactation. sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Vitamin E Can neutralise free Non-compliance with the Regulation maintenance of normal radicals and help because on the basis of the scientific cardiac function maintain a healthy evidence assessed, this claimed effect heart. for this food has not been substantiated.

2011;9(6):2273

Non-authorised

4253

2011;9(6):2212

Non-authorised

1495

2011;9(4):2082

Non-authorised

1622

2010;8(10):1816

Non-authorised

166

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate foods and beverages

Carbohydrate after exercise maximises muscle glycogen replacement. High GI carbohydrate post exercise results in higher muscle glycogen levels after 24 hours than low GI. Liquid carbohydrate is as effective as a solid form for glycogen resynthesis. Replaces glycogen stores used during exercise. Consumption at frequent intervals maintains enhanced muscle glycogen synthesis. Helps recovery and enhances subsequent performance / endurance capacity / delayed onset of fatigue. Carbohydrate during first hour after exercise assures maximal muscle glycogen resynthesis rate and

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

471

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

speed of recovery Clarification provided Carbohydrate after exercise maximises muscle glycogen replacement. High GI carbohydrate post exercise results in higher muscle glycogen levels after 24 hours than low GI. Liquid carbohydrate is as effective as a solid form for glycogen resynthesis. Replaces glycogen stores used during exercise. Consumption at frequent intervals maintains enhanced muscle glycogen synthesis. Helps recovery and enhances subsequent performance / endurance capacity / delayed onset of fatigue. Carbohydrate during first hour after exercise assures maximal muscle glycogen resynthesis

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

rate and speed of recovery

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate foods and beverages

Carbohydrate after exercise maximises muscle glycogen replacement. High GI carbohydrate post exercise results in higher muscle glycogen levels after 24 hours than low GI. Liquid carbohydrate is as effective as a solid form for glycogen resynthesis. Replaces glycogen stores used during exercise. Consumption at frequent intervals maintains enhanced muscle glycogen synthesis. Helps recovery and enhances subsequent performance / endurance capacity / delayed onset of fatigue. Carbohydrate during first hour after exercise assures maximal muscle glycogen resynthesis rate and

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

1277

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

speed of recovery. Clarification provided Carbohydrate after exercise maximises muscle glycogen replacement. High GI carbohydrate post exercise results in higher muscle glycogen levels after 24 hours than low GI. Liquid carbohydrate is as effective as a solid form for glycogen resynthesis. Replaces glycogen stores used during exercise. Consumption at frequent intervals maintains enhanced muscle glycogen synthesis. Helps recovery and enhances subsequent performance / endurance capacity / delayed onset of fatigue. Carbohydrate during first hour after exercise assures maximal muscle glycogen resynthesis

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

rate and speed of recovery. Art.13(1) Carbohydrates CarbohydrateNon-compliance with the Regulation not validated containing foods have a because on the basis of the scientific beneficial impact on evidence assessed, this food is not exercise performance. sufficiently characterised for a Carbohydrate is a key scientific assessment of this claimed energy source prior to effect and the claim could not therefore exercise. be substantiated. Art.13(1) Carbohydrates CarbohydrateNon-compliance with the Regulation not validated containing foods help to because on the basis of the scientific rebuild liver and muscle evidence assessed, this food is not glycogen stores after sufficiently characterised for a exercise. scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Carbohydrates in dairy Carbohydrates in dairy Non-compliance with the Regulation not validated products products have very low because on the basis of the scientific glycemic index (GI); evidence assessed, this food is not Carbohydrates in dairy sufficiently characterised for a products give a very low scientific assessment of this claimed and slow blood glucose effect and the claim could not therefore response. be substantiated. Art.13(1) Carotenoids from fruits and Carotenoids contained Non-compliance with the Regulation not validated vegetables juices in this product ensure because on the basis of the scientific antioxidant evidence assessed, this food is not action/carotenoids sufficiently characterised for a contained in this scientific assessment of this claimed product ensure effect and the claim could not therefore protective effect on the be substantiated. organism. Antioxidant/s 2011;9(6):2244 Non-authorised 459

2011;9(6):2244

Non-authorised

654

2010;8(10):1765

Non-authorised

718, 2912

2011;9(4):2082

Non-authorised

1496

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chlorogenic acids from Coffee

Art.13(1) Choline

Art.13(1) Choline

Chlorogenic acids from coffee extract contributes to keep normal blood glucose levels; Chlorogenic acids from coffee extract has a beneficial effect on glucose metabolism/ insulin metabolism. Choline supports normal neurological functioning. Choline supports nerve impulse transmission. Choline supports cognitive functioning. Choline helps maintain memory and brain function. Choline supports normal neurological functioning. Choline supports nerve impulse transmission. Choline supports cognitive functioning. Choline helps maintain memory and brain function.

Non-compliance with the Regulation maintenance of normal 2011;9(4):2057 because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

1962

Non-compliance with the Regulation Contribution to normal 2011;9(4):2056 because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1502

Non-compliance with the Regulation Maintenance of normal 2011;9(4):2056 because on the basis of the scientific neurological function evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1502

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Citrates as Na-, K-, Ca-, Mg-salts

Art.13(1) ClarinolTM

Citrates (e.g. potassium Non-compliance with the Regulation maintenance of normal 2011;9(7):2302 citrate) reduce dietary because on the basis of the scientific bone acid load. evidence assessed, this claimed effect Citrates (e.g. potassium for this food has not been citrate) help maintain substantiated. acid-base balance and support bone health. Citrates (e.g. potassium citrate) maintain bone strength ClarinolTM is a unique Non-compliance with the Regulation contribution to the 2010;8(10):1794 source of the active because on the basis of the scientific maintenance or form of CLA evidence assessed, this claimed effect achievement of a (conjugated linolenic for this food has not been normal body weight acid) that reduces the substantiated. body fat without reducing muscle mass, it reduces subcutaneous fat and the excess weight is gone for good. ClarinolTM prevents fat redeposition (anti yoyo efect). ClarinolTM influences the metabolism speed increase and suppresses its decline particularly at night.

Non-authorised

330

Non-authorised

3165

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Co-Enzyme Q 10

Art.13(1) Co-Enzyme Q 10

Art.13(1) Co-Enzyme Q 10

Art.13(1) Coenzyme Q10;(Ubiquinone)

Coenzyme Q10 is Non-compliance with the Regulation contribution to normal 2010;8(10):1793 necessary for the because on the basis of the scientific energy-yielding energy metabolism and evidence assessed, this claimed effect metabolism the transformation of for this food has not been food into physiological substantiated. energy. Coenzyme Q10 supports energy production. Coenzyme Q10 Non-compliance with the Regulation maintenance of normal 2010;8(10):1793 maintains a healthy because on the basis of the scientific blood cholesterol heart. May help evidence assessed, this claimed effect concentrations maintain healthy blood for this food has not been pressure. May help substantiated. maintain healthy cholesterol levels Coenzyme Q10 Non-compliance with the Regulation maintenance of normal 2010;8(10):1793 maintains a healthy because on the basis of the scientific blood pressure heart. May help evidence assessed, this claimed effect maintain healthy blood for this food has not been pressure. May help substantiated. maintain healthy cholesterol levels Coenzyme Q10 may Non-compliance with the Regulation increase in endurance 2010;8(10):1793 enhance the physical because on the basis of the scientific capacity and/or endurance.;Coenzyme evidence assessed, this claimed effect endurance performance Q10 may enhance sport for this food has not been performance in those substantiated. who have reduced performance but are free from organic lesions

Non-authorised

1720

Non-authorised

1721

Non-authorised

1721

Non-authorised

1913

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coenzyme Q10

Coenzyme Q10 may help maintain healthy brain function

Art.13(1) Coffee

Art.13(1) Buckwheat extract containing flavonoidmineral (troxerutin - zinc) complex (Coldizin)

Art.13(1) Collagen

Coffee is a major dietary source of antioxidants. Antioxidants from dietary sources: protect you from free radicals; protect your cells and tissues from oxidation; antioxidants help strengthen our body's natural defences against oxidative stress. Coldizin helps support Non-compliance with the Regulation Immune system 2011;9(6):2228 the immune system because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Collagen can/could Non-compliance with the Regulation maintenance of normal 2011;9(6):2247 contribute to the because on the basis of the scientific joints maintenance of the evidence assessed, this claimed effect healthy function of for this food has not been joints. substantiated.

Non-compliance with the Regulation contribution to normal 2010;8(10):1793 because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation Protection of DNA, 2011;9(4):2057 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1511

Non-authorised

1099

Non-authorised

1482

Non-authorised

659

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Collagen

Art.13(1) Bovine colostrum

Art.13(1) Christe marine

Collagen is a natural Non-compliance with the Regulation Maintenance of 2011;9(6):2228 component of the skin. because on the basis of the scientific structure and elasticity Helps the skin to evidence assessed, this claimed effect of the skin preserve its firmness has not been linked to a function of the and elasticity. body, as required by Article 13 of the Has beneficial effect in Regulation. the maintenance of skin firmness and elasticity. Colostrum helps Non-compliance with the Regulation not validated 2011;9(4):2048 athletes maintain a because on the basis of the scientific healthy immune system evidence assessed, this food is not during intense training sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Combat la formation Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 des radicaux libres because on the basis of the scientific proteins and lipids from Clarification provided evidence assessed, this claimed effect oxidative damage acts against agefor this food has not been accelerating free substantiated. radicals/ serves as a protective antioxidant/has antioxidative properties

Non-authorised 1950 (expiry of transitional period 02/01/2014)

Non-authorised

1473

Non-authorised

2527

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Christe marine

Art.13(1) Christe marine

Combat la formation des radicaux libres Clarification provided acts against ageaccelerating free radicals/ serves as a protective antioxidant/has antioxidative properties Combat la formation des radicaux libres Clarification provided acts against ageaccelerating free radicals/ serves as a protective antioxidant/has antioxidative properties

Non-compliance with the Regulation antioxidant activity, 2010;8(10):1752 because on the basis of the scientific antioxidant content, and evidence assessed, this claimed effect antioxidant properties for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

2527

Non-compliance with the Regulation protection of cells from 2010;8(10):1752 because on the basis of the scientific premature aging evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

2527

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carotte racine

Combat la formation Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 des radicaux libres because on the basis of the scientific proteins and lipids from Protection cellulaire evidence assessed, this claimed effect oxidative damage active for this food has not been Nourrit et protge la substantiated. peau Protge la peau des agressions extrieures Active et prolonge le bronzage Clarification provided Helps to keep the skin healthy/helps to retard skin aging Helps to protect your skin from excessive UVradiation and sunburns Can promote healthy skin pigmentation and tanning Antioxidant that protects the body's cells/Has an antioxidant action that helps to neutralize free radicals and counteracts cellular ageing

Non-authorised

2522

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Germe de bl

Non-compliance with the Regulation protection of cells from because on the basis of the scientific premature aging evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Gele Royale Combattre la fatigue Non-compliance with the Regulation not validated intellectuelle et because on the basis of the scientific physique, le surmenage evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Creatine and carbohydrate Combined creatine and Non-compliance with the Regulation Increase in muscle carbohydrate increases because on the basis of the scientific creatine stores muscle creatine stores evidence assessed, this claimed effect compared to creatine for this food is not a beneficial alone. physiological effect as required by the Helps deliver creatine to Regulation. the muscle effectively. Creatine retention is increased when consumed with carbohydrate. Art.13(1) Whey Protein Combined with exercise Non-compliance with the Regulation growth or maintenance and a hypercaloric diet, because on the basis of the scientific of muscle mass whey protein supports evidence assessed, this claimed effect muscle growth for this food has not been substantiated.

Combat la formation des radicaux libres. Lutte contre le vieillissement cellulaire. Anti-oxidant

2010;8(10):1762

Non-authorised

2616

2011;9(4):2083

Non-authorised

1982

2011;9(6):2228

Non-authorised

544

2010;8(10):1818

Non-authorised

419

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Art.13(1) Bovine colostrum

Art.13(1) Bovine colostrum

Art.13(1) CLA (acido linoleico coniugato)

Combined with exercise Non-compliance with the Regulation reduction of body fat and a hypocaloric diet, because on the basis of the scientific mass during energy whey protein supports evidence assessed, this claimed effect restriction and your fat loss goals. for this food has not been resistance training substantiated. Combined with exercise Non-compliance with the Regulation not validated and diet, colostrum because on the basis of the scientific supports muscle growth evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Combined with regular Non-compliance with the Regulation not validated training, colostrum can because on the basis of the scientific improve in exercise evidence assessed, this food is not performance sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Con acido linoleico Non-compliance with the Regulation increase in lean body coniugato che AIUTA A because on the basis of the scientific mass DIMAGRIRE evidence assessed, this claimed effect Clarification provided for this food has not been Conjugated linoleic acid substantiated. can support lean body mass

2010;8(10):1818

Non-authorised

420

2011;9(4):2048

Non-authorised

1475

2011;9(4):2048

Non-authorised

1474

2010;8(10):1794

Non-authorised

731

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Phaseolamine (proteina concentrata di fagiolo Phaseolus vulgaris)

Art.13(1) Arginine

Art.13(1) Almonds

Con proteina Non-compliance with the Regulation reduction in body 2011;9(6):2253 concentrata di fagiolo because on the basis of the scientific weight che AIUTA A evidence assessed, this claimed effect DIMAGRIRE. for this food has not been Clarification provided substantiated. With concentrated bean proteins, which contributes to weight reduction. Conditionally-essential Non-compliance with the Regulation Immune system 2011;9(4):2051 amino acid that plays an because on the basis of the scientific functions important role in the evidence assessed, this claimed effect growth and immune for this food is not sufficiently defined system. to be able to be assessed and the It supports tissue claim could not therefore be growth acceleration. substantiated. Consuming a handful Non-compliance with the Regulation maintenance of normal 2011;9(4):2036 (28 grams) of almonds because on the basis of the scientific blood LDL-cholesterol a day as part of a diet evidence assessed, this claimed effect concentrations low in saturated fat, for this food has not been helps to maintain substantiated. healthy blood cholesterol and promotes a healthy heart

Non-authorised

1701

Non-authorised

455

Non-authorised

1131

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Claim

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Peanuts, Peanut butter, Peanut oil

Consuming a small Non-compliance with the Regulation maintenance of normal 2011;9(4):2045 handful, about 30 because on the basis of the scientific blood LDL-cholesterol grams, of peanuts a day evidence assessed, this claimed effect concentrations as part of a diet low in for this food has not been saturated fat helps to substantiated. achieve healthy cholesterol levels and promotes heart health. Consuming two tablespoons, about 30g, of peanut butter a day as part of a diet low in saturated fat helps to achieve healthy cholesterol levels and promotes heart health. Consuming two tablespoons, about 30 grams of peanut oil a day as part of a diet low in saturated fat helps to achieve healthy cholesterol levels and promotes heart health.

Non-authorised

1284

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Status

Entry Id

Art.13(1) Carbohydrate foods and beverages

Consumption before Non-compliance with the Regulation reduction in the rated and during exercise because on the basis of the scientific perceived enhances feelings of evidence assessed, this claimed effect exertion/effort during energetic arousal which for this food has not been exercise may impact on task substantiated. persistence and performance Reduces the perception of athletic fatigue Helps maintain alertness / mood Helps reduce the perception of effort, making you feel better during exercise A high carbohydrate diet helps to reduce feelings of fatigue / perceived effort during prolonged exercise

2011;9(6):2211

Non-authorised

460

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate electrolyte drinks

Consumption before Non-compliance with the Regulation reduction in the rated and during exercise because on the basis of the scientific perceived enhances feelings of evidence assessed, this claimed effect exertion/effort during energetic arousal which for this food has not been exercise may impact on task substantiated. persistence and performance Helps reduce the perception of effort, making you feel better during exercise Reduces the perception of athletic fatigue. Helps maintain alertness during later stages of exercise Helps improve readiness/ motivation Helps enhance feelings of pleasure

2011;9(6):2211

Non-authorised

468

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate foods and beverages

Consumption before and during exercise enhances feelings of energetic arousal which may impact on task persistence and performance. Reduces the perception of athletic fatigue. Helps maintain alertness / mood. Helps reduce the perception of effort, making you feel better during exercise. A high carbohydrate diet helps to reduce feelings of fatigue / perceived effort during prolonged exercise.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

1278

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Medium Chain Triglycerides;;MCT;

Consumption of Non-compliance with the Regulation reduction in body Medium Chain because on the basis of the scientific weight Triglycerides (MCT) evidence assessed, this claimed effect inside the normal for this food has not been suggested fat substantiated. consumption contributes to keep the healthy balanced body weight and helps to avoid fat deposition, with special regards to the abdominal fat.;;MCT helps to increase energy expenditure in comparison to the long chain fatty acides by increasing the metabolic rate. Art.13(1) Carbohydrate sources with Consumption of low GI Non-compliance with the Regulation not validated low glycaemic index (GI (low glycaemic index) because on the basis of the scientific <55), e.g. legumes, foods with in the healthy evidence assessed, this food is not vegetables, whole grain diet (low glycaemic load sufficiently characterised for a cereals - GL) can contribute to scientific assessment of this claimed the maintenance of the effect and the claim could not therefore normal blood sugar be substantiated. level, blood lipid level (triglyceride) and body mass.

2011;9(6):2240

Non-authorised

677

2010;8(2):1491

Non-authorised

1300

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Prot*omegaein

Art.13(1) Whey Prot*omegaein

Art.13(1) Berry seed oils (supercritical carbon dioxide extract)

Art.13(1) Fructo-oligosaccharide

Art.13(1) Fructo-oligosaccharide

Consumption of whey in Non-compliance with the Regulation growth or maintenance 2010;8(10):1818 conjunction with because on the basis of the scientific of muscle mass resistance exercise evidence assessed, this claimed effect supports an increase in for this food has not been lean body mass and substantiated. strength. Consumption of whey in Non-compliance with the Regulation increase in muscle 2010;8(10):1818 conjunction with because on the basis of the scientific strength resistance exercise evidence assessed, this claimed effect supports an increase in for this food has not been lean body mass and substantiated. strength. Contain a lot of Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 antioxidants. because on the basis of the scientific content, and antioxidant evidence assessed, this claimed effect properties for this food is not a beneficial physiological effect as required by the Regulation. Contains Prebiotic Non-compliance with the Regulation decreasing potentially 2010;8(10):1809 Promotes growth of because on the basis of the scientific pathogenic gastrohealthy organisms evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated. Contains Prebiotic Non-compliance with the Regulation increasing numbers of 2010;8(10):1809 Promotes growth of because on the basis of the scientific gastro-intestinal healthy organisms evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

429

Non-authorised

429

Non-authorised

570

Non-authorised

780

Non-authorised

780

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Galactoligo-saccharide Contains Prebiotic (Arabino-galactans or Gum Promotes growth of Acacia) healthy organisms

Non-compliance with the Regulation decreasing potentially 2010;8(10):1809 because on the basis of the scientific pathogenic gastroevidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated. Art.13(1) Galactoligo-saccharide Contains Prebiotic Non-compliance with the Regulation increasing numbers of 2010;8(10):1809 (Arabino-galactans or Gum Promotes growth of because on the basis of the scientific gastro-intestinal Acacia) healthy organisms evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Aronia melanocarpa Contains antioxidant/s. Non-compliance with the Regulation protection of DNA, 2011;9(6):2246 (Common Name : Is a source of because on the basis of the scientific proteins and lipids from Chokeberry) antioxdiant/s. evidence assessed, this claimed effect oxidative damage With antioxidant/s. for this food has not been Natural source of substantiated. beneficial bioactive compounds: polyphenols (anthocyanins, flavonols, tannins), that help maintain optimum antioxidant status of the body.

Non-authorised

760

Non-authorised

760

Non-authorised

1997

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carica papaya (Common Name : Papaya)

Art.13(1) Vaccinium macrocarpon (Common Name : Cranberry)

Contains antioxidant/s; Non-compliance with the Regulation not validated 2011;9(4):2083 Is a source of because on the basis of the scientific antioxdiant/s. With evidence assessed, this food is not antioxidant/s. sufficiently characterised for a Antioxidant activity 'scientific assessment of this claimed Contributes to the effect and the claim could not therefore protection against be substantiated. oxidation; - contributes to the protection against free radicals Contains antioxidant/s; Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 Is a source of because on the basis of the scientific proteins and lipids from antioxdiant/s. With evidence assessed, this claimed effect oxidative damage antioxidant/s. Contains for this food has not been naturally occuring substantiated. antioxidants Antioxidants help protect you from free radicals Antioxidants help protect your cells and tissues from oxidation

Non-authorised

2007

Non-authorised

2154

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lycium Barbarum (Common Name : Wolfberry)

Art.13(1) Aspalathus linearis (Common Name : Rooibos/Red bush)

Contains antioxidant/s; Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 Is a source of because on the basis of the scientific proteins and lipids from antioxdiant/s. With evidence assessed, this claimed effect oxidative damage antioxidant/s. for this food has not been Contributes to the cell substantiated. protection against free radicals Can protect your cells and tissues from oxidation Can contribute to the total antioxidant capacity of the body Contains antioxidant/s; Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 Is a source of because on the basis of the scientific proteins and lipids from antioxdiant/s. With evidence assessed, this claimed effect oxidative damage antioxidant/s. Has for this food has not been antioxidant properties substantiated. Acts as free radical scavengers Contains naturally occuring antioxidants Antioxidants help protect you from free radicals Antioxidants help protect your cells and tissues from oxidation Antioxidants contribute to the total antioxidant capacity of the body and help strengthen our bodys defences

Non-authorised

2083

Non-authorised

1999

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chlorophyll in sprouted seed

Contains chlorophyll, a natural anti-oxidant giving enhanced defence against free radicals. Art.13(1) Standardized tomato Contains naturally extract [Oleoresin extractedoccurring antioxidants from ripe fruits of /for cells Licopersicum aesculentum, protection/helps protect solvent of extraction Ethyl cells from free radical acetate, 5% lycopene damage, Lycopene is an antioxidant and helps to maintain intact cell DNA, it contributes to healthy ageing, by maintaining intact cell DNA

Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Non-compliance with the Regulation protection of DNA, 2011;9(4):2031 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1921

Non-authorised

2142

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Emblica officinalis (common name: Emblica officinalis)

Art.13(1) Anthocyanins

Contains naturally Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 occurring antioxidants because on the basis of the scientific proteins and lipids from Antioxidants help evidence assessed, this claimed effect oxidative damage protect you from for this food has not been radicals which cause substantiated. cell damage Antioxidants help protect your cells and tissues from oxidative damage Antioxidants contribute to the total antioxidant capacity of the body and may help strengthen our bodys defences; Contains antioxidant/s Is a source of antioxdiant/s. With antioxidant/s. Contains naturally Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 occurring antioxidants, because on the basis of the scientific proteins and lipids from which may help to evidence assessed, this claimed effect oxidative damage protect against the for this food has not been damage caused by free substantiated. radicals, as part of a healthy lifestyle.

Non-authorised

2181

Non-authorised

1445

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bioalfa plus e biogenina, associati a sostanze antiossidanti (quercitina, zinco e rame) [1]

Art.13(1) Levure de bire

Contrastano gli effetti Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 nocivi dei radicali liberi because on the basis of the scientific proteins and lipids from sul bulbo del capello e evidence assessed, this claimed effect oxidative damage controbuiscono a for this food has not been ridargli vitalit. substantiated. Clarification provided work against the negative effect of free radicals on the hair bulb revitalizing the hair Contribue la beaut Non-compliance with the Regulation Prevention or treatment 2011;9(6):2228 de la peau because on the basis of the scientific of acne Favorise l'clat et la evidence assessed, this claimed effect vitalit de la peau attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods.

Non-authorised

1692

Non-authorised

2552

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Laitance de poisson

Contribue stimuler Non-compliance with the Regulation contribution to normal l'activit intellectuelle et because on the basis of the scientific cognitive function renforcer la mmoire. evidence assessed, this claimed effect A utiliser en cas for this food has not been d'efforts intellectuels. substantiated. Favorise les facults de concentration. Clarification provided May improve memory/may improve cognitive performance/ phospholipids play a role in healthy brain functions/supports memory and concentration/increase concentration and make the memory more effective.

2011;9(6):2248

Non-authorised

1894

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coquille d'hutre

Contribue un bon Non-compliance with the Regulation maintenance of normal 2010;8(10):1725 cholestrol. Aide because on the basis of the scientific blood HDL-cholesterol matriser le cholesterol. evidence assessed, this claimed effect concentrations Clarification provided for this food has not been Oyster shells are rich substantiated. source of calcium that contributes to healthy blood cholesterol level/ Oyster shells are a rich source of calcium that helps to maintain normal cholesterol level/Oyster shells are a rich source of calcium that decreases LDL cholesterol and increase HDL cholesterol.

Non-authorised

1893

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coquille d'hutre

Contribue un bon Non-compliance with the Regulation maintenance of normal 2010;8(10):1725 cholestrol. Aide because on the basis of the scientific blood LDL-cholesterol matriser le cholesterol. evidence assessed, this claimed effect concentrations Clarification provided for this food has not been Oyster shells are rich substantiated. source of calcium that contributes to healthy blood cholesterol level/ Oyster shells are a rich source of calcium that helps to maintain normal cholesterol level/Oyster shells are a rich source of calcium that decreases LDL cholesterol and increase HDL cholesterol.

Non-authorised

1893

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coquille d'hutre

Contribue un bon Non-compliance with the Regulation maintenance of normal 2010;8(10):1725 cholestrol. Aide because on the basis of the scientific blood HDL-cholesterol matriser le cholesterol. evidence assessed, this claimed effect concentrations Clarification provided for this food has not been Oyster shells are rich substantiated. source of calcium that contributes to healthy blood cholesterol level/ Oyster shells are a rich source of calcium that helps to maintain normal cholesterol level/Oyster shells are a rich source of calcium that decreases LDL cholesterol and increase HDL cholesterol.

Non-authorised

349

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coquille d'hutre

Art.13(1) Brewer's yeast (Saccharomyces cerevisae)

Contribue un bon Non-compliance with the Regulation maintenance of normal 2010;8(10):1725 cholestrol. Aide because on the basis of the scientific blood LDL-cholesterol matriser le cholesterol. evidence assessed, this claimed effect concentrations Clarification provided for this food has not been Oyster shells are rich substantiated. source of calcium that contributes to healthy blood cholesterol level/ Oyster shells are a rich source of calcium that helps to maintain normal cholesterol level/Oyster shells are a rich source of calcium that decreases LDL cholesterol and increase HDL cholesterol. Contribute to a normal Non-compliance with the Regulation reduction of gastro2011;9(6):2248 intestinal fonction because on the basis of the scientific intestinal discomfort through promotion of evidence assessed, this claimed effect beneficial for this food has not been microflora/helps to substantiated. manage diarrhea episodes/has an antidiarrheal effect through anti-microbial activity on pathogenic intestinal bacteria.

Non-authorised

349

Non-authorised

4313

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamine B8 : Vitamin B8 orContribute to improve vitamin H (biotin) nail's resistance

Art.13(1) Punica granatum (Common Name : Pomgranade)

Art.13(1) Pomegranate

Art.13(1) Sinapis alba (Common Name : White mustard)

Non-compliance with the Regulation maintenance of normal because on the basis of the scientific nails evidence assessed, this claimed effect for this food has not been substantiated. Contributes to a healthy Non-compliance with the Regulation maintenance of normal cholesterol level and because on the basis of the scientific blood cholesterol healthy blood vessels / evidence assessed, this claimed effect concentrations antioxidants of for this food has not been pomegranate can be substantiated. helpful for a healthy heart and arteries / antioxidants of pomegranate can help cells and arteries in their physiological function. Contributes to a healthy Non-compliance with the Regulation maintenance of normal cholesterol level and because on the basis of the scientific blood cholesterol healthy blood vessels. evidence assessed, this claimed effect concentrations for this food has not been substantiated. Contributes to appetite / Non-compliance with the Regulation changes in bowel helps to support the because on the basis of the scientific function digestion / helps to evidence assessed, this claimed effect support the digestive for this food has not been juice flow / contributes substantiated. to the gastro-intestinal movement.

2010;8(10):1728

Non-authorised

2877

2010;8(10):1750

Non-authorised

2107

2010;8(10):1750

Non-authorised

1162

2011;9(6):2246

Non-authorised

2141

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sinapis alba (Common Name : White mustard)

Art.13(1) SOIA ISOFLAVONI

Art.13(1) Purslane (Portulaca oleracea L.)

Contributes to appetite / Non-compliance with the Regulation increase in appetite 2011;9(6):2246 helps to support the because on the basis of the scientific after unintentional digestion / helps to evidence assessed, this claimed effect weight loss leading to support the digestive for this food has not been an increase in energy juice flow / contributes substantiated. intake to the gastro-intestinal movement. Contributes to Non-compliance with the Regulation cardiovascular health 2011;9(7):2264 cardiovascular health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Contributes to cell Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 protection form the because on the basis of the scientific proteins and lipids from damage caused by free evidence assessed, this claimed effect oxidative damage radical, due to its for this food has not been antioxidant properties. substantiated. Helps to protect the body against free radicals. Provides antioxidant protection. Protects the body's cells. Can protect you from radicals which cause cell damage. Can protect your cells and tissues from oxidative damage. Can contribute to the total antioxidant capacity of the body.

Non-authorised

2141

Non-authorised

3587

Non-authorised

2734

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cyamopsis tetragonolobus Contributes to control of Non-compliance with the Regulation long-term maintenance 2009;7(9):1287 (Guar) sugar level because on the basis of the scientific of normal blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated. Art.13(1) Eicosapentaenoic acid Contributes to Non-compliance with the Regulation enhancement of mood 2010;8(10):1736 (EPA) emotional balance / because on the basis of the scientific helps maintain a evidence assessed, this claimed effect positive mood. for this food has not been substantiated. Art.13(1) Triticum sativum Contributes to enhance Non-compliance with the Regulation contribution to body 2010;8(10):1799 your body's resistance; because on the basis of the scientific defences against evidence assessed, this claimed effect external agents for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Eicosapentaenoic acid Contributes to good Non-compliance with the Regulation protection of blood 2010;8(10):1736 (EPA) quality of cholesterol because on the basis of the scientific lipids from oxidative particles. evidence assessed, this claimed effect damage Contributes to good for this food has not been quality cholesterol. substantiated. Art.13(1) Docosahexaenoic acid Contributes to good Non-compliance with the Regulation protection of blood 2010;8(10):1734 (DHA) quality of cholesterol because on the basis of the scientific lipids from oxidative particles. Contributes to evidence assessed, this claimed effect damage good quality cholesterol. for this food has not been substantiated. Art.13(1) Folic Acid (Vitamin B9) Contributes to healthy Non-compliance with the Regulation function of blood 2009;7(9):1213 arteries and vessels; because on the basis of the scientific vessels Helps promote heart evidence assessed, this claimed effect health. for this food has not been substantiated.

Non-authorised

2429

Non-authorised

633

Non-authorised

2344

Non-authorised

636

Non-authorised

630

Non-authorised

94

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Conjugated linoleic acid (CLA)

Contributes to healthy blood glucose level

Art.13(1) Hyaluronic acid / Sodium Hyaluronate

Art.13(1) Wheat (Triticum vulgare)

Non-compliance with the Regulation increase in insulin 2010;8(10):1794 because on the basis of the scientific sensitivity evidence assessed, this claimed effect for this food has not been substantiated. Contributes to joint Non-compliance with the Regulation maintenance of joints 2009;7(9):1266 mobility and lubrication. because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Contributes to maintain Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 a healthy skin. because on the basis of the scientific skin hydration Contributes to skin evidence assessed, this claimed effect hydration/ moisturizing. for this food has not been Helps to protect the substantiated. skin. Helps to support skin's natural defenses against UV-radiations. Antioxidants help your skin to combat the production of free radicals during exposure to the sun.

Non-authorised

1517

Non-authorised

1731

Non-authorised

600

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat (Triticum vulgare)

Contributes to maintain Non-compliance with the Regulation protection of the skin 2010;8(10):1762 a healthy skin. because on the basis of the scientific from photo-oxidative Contributes to skin evidence assessed, this claimed effect (UV-induced) damage hydration/ moisturizing. for this food has not been Helps to protect the substantiated. skin. Helps to support skin's natural defenses against UV-radiations. Antioxidants help your skin to combat the production of free radicals during exposure to the sun. Art.13(1) Monomthylsilanetriol: Contributes to Non-compliance with the Regulation maintenance of normal 2011;9(6):2259 other substance with maintenance of healthy because on the basis of the scientific bone nutritionnal or physiological skin, joints and bone. evidence assessed, this claimed effect effects -Contributes to for this food has not been maintenance of strong substantiated. hairs and nails. -Contributes to the structure of blood vessels. -Supports mobility and flexibility by contribution to the structure of articular cartilage

Non-authorised

600

Non-authorised

1945

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Monomthylsilanetriol: Contributes to Non-compliance with the Regulation contribution to normal 2011;9(6):2259 other substance with maintenance of healthy because on the basis of the scientific formation of collagen nutritionnal or physiological skin, joints and bone. evidence assessed, this claimed effect and connective tissue effects -Contributes to for this food has not been maintenance of strong substantiated. hairs and nails. -Contributes to the structure of blood vessels. -Supports mobility and flexibility by contribution to the structure of articular cartilage Art.13(1) Monomthylsilanetriol: Contributes to Non-compliance with the Regulation maintenance of normal 2011;9(6):2259 other substance with maintenance of healthy because on the basis of the scientific joints nutritionnal or physiological skin, joints and bone. evidence assessed, this claimed effect effects -Contributes to for this food has not been maintenance of strong substantiated. hairs and nails. -Contributes to the structure of blood vessels. -Supports mobility and flexibility by contribution to the structure of articular cartilage

Non-authorised

1945

Non-authorised

1945

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chitosan

Art.13(1) Phenylalanine

Non-compliance with the Regulation increased alertness because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Inositol Contributes to mental Non-compliance with the Regulation cognitive function performance because on the basis of the scientific Contributes to mental evidence assessed, this claimed effect concentration for this food has not been substantiated. Art.13(1) Lentinula edodes Contributes to natural Non-compliance with the Regulation Immune (Common Name : Shitake) immunological defences because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Contributes to management of weight control -can help in the reduction of body weight -can help to the control of weight by reducing the quantity of fat absorbed from the diet Contributes to mental activity. Stimulates mental alertness

Non-compliance with the Regulation reduction in body because on the basis of the scientific weight evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2214

Non-authorised

1499

2010;8(10):1748

Non-authorised

1629

2009;7(9):1304

Non-authorised

1588

2011;9(4):2061

Non-authorised

3774

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lentinus edodes (Common Contributes to natural Non-compliance with the Regulation Stimulation of Name : Shiitake) immunological defences because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Pleurotus ostreatus (oyster Contributes to natural Non-compliance with the Regulation Immune mushroom) immunological defences because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Phytosterols (mixture of Contributes to normal Non-compliance with the Regulation maintenance of normal Beta-sitosterol, functioning of prostate because on the basis of the scientific prostate size and Campesterol, Stigmasterol, and urinary tract evidence assessed, this claimed effect normal urination Brassicasterol, for this food has not been Stigmastanol, Ergostanol, substantiated. Campestanol) Art.13(1) Phytosterols (mixture of Contributes to normal Non-compliance with the Regulation maintenance of normal Beta-sitosterol, functioning of urinary because on the basis of the scientific prostate size and Campesterol, Stigmasterol, tract evidence assessed, this claimed effect normal urination Brassicasterol, for this food has not been Stigmastanol, Ergostanol, substantiated. Campestanol) Art.13(1) Cystine (wheat extract) Contributes to normal Non-compliance with the Regulation maintenance of normal hair growth because on the basis of the scientific hair evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2061

Non-authorised

2075

2011;9(4):2061

Non-authorised

3521

2010;8(10):1813

Non-authorised

714

2010;8(10):1813

Non-authorised

1635

2010;8(10):1795

Non-authorised

4297

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lycopodium clavatum

Non-compliance with the Regulation Kidneys health, 2010;8(10):1742 because on the basis of the scientific urinary health, evidence assessed, this claimed effect bladder health, health for this food is not sufficiently defined of lower urinary tract, to be able to be assessed and the blood health, claim could not therefore be elimination, "urinary substantiated. system benefits" and/or supports/promotes the excretory function of the kidney Art.13(1) Aspalathus linearis Contributes to optimal Non-compliance with the Regulation reduction of gastro2011;9(6):2248 (Common Name : relaxation because on the basis of the scientific intestinal discomfort Rooibos/Red bush) / helps to support the evidence assessed, this claimed effect relaxation. for this food has not been substantiated. Art.13(1) Raphanus sativus var niger Contributes to the Non-compliance with the Regulation reduction of gastro2011;9(6):2248 (Common Name : Radish, elimination function of because on the basis of the scientific intestinal discomfort Black radish, Japanese the gastrointestinal tract evidence assessed, this claimed effect radish, Daikon) / contributes to bile flow for this food has not been fonction / supports substantiated. healthy liver activity / contributes to healthy digestion/digestive wellbeingl/liver well-being. Art.13(1) SOIA ISOFLAVONI Contributes to the Non-compliance with the Regulation Reduction of vasomotor 2011;9(7):2264, female hormonal because on the basis of the scientific symptoms associated 2012;10(8):2847 balance during evidence assessed, the evidence with menopause clymaterium. Helps in provided is insufficient to substantiate case of augmented this claimed effect for this food. request of nutrients.

Contributes to normal urinary elimination functions

Non-authorised

2296

Non-authorised

2000

Non-authorised

2124

Non-authorised 3590 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Collagen hydrolysate

Contributes to the Non-compliance with the Regulation maintenance of normal 2011;9(6):2247 functioning of cartilage because on the basis of the scientific joints building cells. evidence assessed, this claimed effect Supports the (natural) for this food has not been regeneration of joint substantiated. cartilage. Stimulates the build-up of joint cartilage. Contributes to improved joint functioning and joint mobility. Contributes to joint comfort. Provides the building blocks (peptides) for the biosynthesis of cartilage. Provides strength, flexibility and support to skin connective tissues, ligaments, tendons, bones and other parts of the body. Art.13(1) Omega 3-Fatty acids Contributes to the good Non-compliance with the Regulation Immunomodulating 2010;8(10):1796 containing functioning of the because on the basis of the scientific agent eicosapentaenoic acid-EPAimmunity system. / evidence assessed, this claimed effect and docosahexaenoic acid for this food is not sufficiently defined (DHA) to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

1513

Non-authorised

4690

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Tomato extract containing Contributes to the lycopene maintenance of a healthy cardiovascular system. Maintains cardiovascular health Art.13(1) Lycopene Contributes to the maintenance of healthy skin when exposed to sun light. (Avoid sunburns by using an effective sun screen. Lycopene is not a replacement for sun screens). Art.13(1) Phosphatidyl choline / Contributes to the lecithin memory function. Contributes against memory problems associated with aging. Art.13(1) Phosphatidyl choline / Contributes to the lecithin memory function. Contributes to mental and cognitive function.

Non-compliance with the Regulation protection of DNA, 2011;9(4):2031 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Non-compliance with the Regulation protection of the skin because on the basis of the scientific from UV-induced evidence assessed, this claimed effect (including photofor this food has not been oxidative) damage substantiated. 2011;9(4):2031

Non-authorised

1662

Non-authorised

1607

Non-compliance with the Regulation contribution to normal because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation contribution to normal because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1741

Non-authorised

710

2010;8(10):1741

Non-authorised

1631

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Caffeine (from tea/coffee/chocolate or added in pure form)

Art.13(1) Bovine lactoferrin

Contributes to the mobilisation of fat stores. Contributes ton the stimulation of fat release. Helps to increase fat burning. Contributes to the oxidation of stored fats. Helps generate a negative energy balance. Contributes to increased calorie burning. Contributes to the natural defences

Non-compliance with the Regulation increased fat oxidation 2011;9(4):2054 because on the basis of the scientific leading to a reduction in evidence assessed, this claimed effect body fat mass for this food has not been substantiated.

Non-authorised

735

Art.13(1) Griffola fondosa (Common Contributes to the Name : Maitake) natural defences /support of natural resistance

Non-compliance with the Regulation immune defence because on the basis of the scientific against pathogens evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food is not a beneficial physiological effect as required by the Regulation.

2011;9(6):2228

Non-authorised

1477

2011;9(4):2061

Non-authorised

2064

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bromelain

Contributes to the normal functioning of the immune system. Helps maintain the body's natural defences

Art.13(1) Nucleotides

Art.13(1) Lycopene

Art.13(1) Troxerutin

Non-compliance with the Regulation Stimulation of because on the basis of the scientific immunological evidence assessed, this claimed effect responses for this food is not a beneficial physiological effect as required by the Regulation. Contributes to the Non-compliance with the Regulation immune defence normal functioning of because on the basis of the scientific against pathogens the immune evidence assessed, this claimed effect system/supports natural for this food has not been defences substantiated. Contributes to the Non-compliance with the Regulation protection of DNA, normal functioning of because on the basis of the scientific proteins and lipids from the prostate/helps to evidence assessed, this claimed effect oxidative damage maintain a healthy for this food has not been prostate/helps to keep substantiated. your prostate in shape/helps to reduce oxidative damage of prostate cells and tissue/helps to maintain intact DNA in prostate tissue Contributes to the Non-compliance with the Regulation maintenance of normal functioning of because on the basis of the scientific elasticity and strength the veins. evidence assessed, this claimed effect of the venous walls for this food has not been substantiated.

2011;9(4):2061

Non-authorised

1479

2011;9(4):2066

Non-authorised

1623

2011;9(4):2031

Non-authorised

1609

2011;9(6):2246

Non-authorised

1670

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L/arginine

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Contributes to the Non-compliance with the Regulation Improvement of 2011;9(4):2051 synthesis of creatinine because on the basis of the scientific endothelium-dependent and nitric oxide, with evidence assessed, this claimed effect vasodilation important role in for this food has not been dilatation and relaxation substantiated. of blood vessels. fish oil (EPA, DHA) Contributes to thin the Non-compliance with the Regulation Membranes cell 2011;9(4):2078 blood because on the basis of the scientific structure evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Copper Copper contributes to Non-compliance with the Regulation cholesterol metabolism 2009;7(9):1211 the cholesterol and because on the basis of the scientific glucose evidence assessed, this claimed effect for this food has not been substantiated. Copper Copper contributes to Non-compliance with the Regulation glucose metabolism 2009;7(9):1211 the cholesterol and because on the basis of the scientific glucose evidence assessed, this claimed effect for this food has not been substantiated. Gamma- linolenic acid;GLACould contribute to the Non-compliance with the Regulation Maintenance of the 2011;9(4):2059 maintenance of the because on the basis of the scientific barrier function of the health of epidermic and evidence assessed, this claimed effect skin connective tissue. for this food has not been substantiated.

Non-authorised

4680

Non-authorised

4295

Non-authorised

369

Non-authorised

369

Non-authorised

676

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta Carotene

Could help to retard Non-compliance with the Regulation protection of the skin skin aging/contributes to because on the basis of the scientific from UV-induced maintain a healthy skin. evidence assessed, this claimed effect (including photoTaken on a regular for this food has not been oxidative) damage basis, beta carotene substantiated. can help to protect your skin from excessive UVradiation and sunburns (Avoid sunburns by using an effective sun screen. Beta carotene is not a replacement for sun screens). Oral supplementation of Beta carotene helps to reduce skin damages from sun and UV light (Avoid sunburns by using an effective sun screen. Beta carotene is not a replacement for sun screens). Can promote healthy skin pigmentation and tanning. The antioxidant properties of Beta carotene can help maintain a healthy and elastic skin.

2011;9(4):2021

Non-authorised

178

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Proanthocyanidins in cranberry juice

Cranberry helps to Non-compliance with the Regulation Defence against 2011;9(6):2215 inhibit the attachment of because on the basis of the scientific bacterial pathogens in certain E-coli bacteria to evidence assessed, the evidence the lower urinary tract the urinary tract provided is insufficient to substantiate this claimed effect for this food. Art.13(1) Cranberry (Lingonberry) Cranberry juice helps to Non-compliance with the Regulation not validated 2011;9(6):2244 juice, (Vaccinium vitis keep the urinary system because on the basis of the scientific idaea, Vaccinium in a healthy condition; evidence assessed, this food is not macrocarpon) Lingonberry juice has a sufficiently characterised for a positive efect on the scientific assessment of this claimed urinary tract; effect and the claim could not therefore be substantiated. Art.13(1) Cranberry (Lingonberry) Cranberry juice helps to Non-compliance with the Regulation not validated 2011;9(6):2244 juice, (Vaccinium vitiskeep the urinary system because on the basis of the scientific idaea, Vaccinium in a healthy condition; evidence assessed, this food is not macrocarpon) Lingonberry juice has a sufficiently characterised for a positive effect on the scientific assessment of this claimed urinary tract; effect and the claim could not therefore Cranberry juice has a be substantiated. beneficial effect on the urinary system Art.13(1) Phenol compounds of Cranberry-lingonberry Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 cranberry and lingonberry juice contains natural because on the basis of the scientific content, and antioxidant (catechins, flavonoids, phenolic compounds evidence assessed, this claimed effect properties phenolic acids, that are healthfor this food is not a beneficial anthocyanins, lignans) + promoting antioxidants. physiological effect as required by the ascorbic acid Regulation. Art.13(1) Creatine Creatine can help Non-compliance with the Regulation increase in endurance 2011;9(7):2303 enhance physical because on the basis of the scientific capacity working capacity at evidence assessed, this claimed effect fatigue threshold for this food has not been substantiated.

Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Dairy (low fat dairy) Dairy in an energy Non-compliance with the Regulation not validated 2011;9(6):2243 *Dairy refers to cows milk, restricted diet helps because on the basis of the scientific yogurt and cheese weight loss. evidence assessed, this food is not Consuming dairy foods, sufficiently characterised for a as part of your weight scientific assessment of this claimed loss diet, will help effect and the claim could not therefore weight loss. be substantiated. Consuming dairy foods, as part of your weight loss diet, will help weight maintenance. Art.13(1) Omega 3-Fatty acids Decreases lipid levels / Non-compliance with the Regulation maintenance of normal 2010;8(10):1796 containing Function in regulation of because on the basis of the scientific blood LDL-cholesterol eicosapentaenoic acid-EPAlipid metabolism / evidence assessed, this claimed effect concentrations and docosahexaenoic acid Reduces lipids and LDL for this food has not been (DHA) -cholesterol levels substantiated. Art.13(1) Beta Alanine Delay onset of fatigue. Non-compliance with the Regulation increase in physical 2010;8(10):1729 Improves short-duration because on the basis of the scientific performance during high intensity evidence assessed, this claimed effect short-term highperformance with lactic for this food has not been intensity exercise acid buffer. substantiated. Increases muscle carnosine, the intracellular buffering agent proposed to be responsible for the beneficial effects on short-duration high intensity exercise.

Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Probiotics (Saccharomyces DiarSafe is a natural boulardii) as contained in support for bowel the probiotic formula health, comfort and DiarSafe: function - Saccharomyces boulardii

Non-compliance with the Regulation not validated 2009;7(9):1247 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Partially Hydrolysed Guar Diet rich in fiber can Non-compliance with the Regulation Maintenance of normal 2010;8(2):1465 Gum (PHGG) help you maintain good because on the basis of the scientific blood cholesterol cardiovascular health evidence assessed, this claimed effect concentrations Dietary fiber helps for this food has not been maintain healthy substantiated. cholesterol levels to promote overall heart health Dietary fiber helps maintain healthy blood pressure to promote overall heart health Diets rich in fiber can help promote healthy triglyceride levels

Non-authorised

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Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Partially Hydrolysed Guar Diet rich in fiber can Non-compliance with the Regulation Maintenance of normal 2010;8(2):1465 Gum (PHGG) help you maintain good because on the basis of the scientific blood concentrations of cardiovascular health evidence assessed, this claimed effect triglycerides Dietary fiber helps for this food has not been maintain healthy substantiated. cholesterol levels to promote overall heart health Dietary fiber helps maintain healthy blood pressure to promote overall heart health Diets rich in fiber can help promote healthy triglyceride levels Art.13(1) Calcium Diet which includes Non-compliance with the Regulation maintenance of normal 2009;7(9):1210 several daily servings of because on the basis of the scientific blood pressure low-fat milk products evidence assessed, the evidence (about 1200 mg of provided is insufficient to substantiate calcium/day) helps to this claimed effect for this food. control blood pressure. Art.13(1) Partially Hydrolysed Guar Dietary fiber helps keep Non-compliance with the Regulation Maintenance of normal 2010;8(2):1465 Gum (PHGG) your blood sugar levels because on the basis of the scientific blood glucose constant evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

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Art.13(1) Partially Hydrolysed Guar Dietary fiber helps Gum (PHGG) maintain a healthy immune system by strengthening your bodys natural defenses. Dietary fiber helps promote overall immune system health. Dietary Fiber helps boost your bodys natural immunity Art.13(1) Dietary fibre Dietary fibre helps to maintain a healthy immune system.

Non-compliance with the Regulation immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1799

Non-authorised

791

Art.13(1) Dietary fibre

Art.13(1) Dietary fibre

Non-compliance with the Regulation not validated 2010;8(10):1735 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Dietary fibre helps to Non-compliance with the Regulation maintenance of normal 2009;7(9):1255 maintain normal blood because on the basis of the scientific blood cholesterol lipid levels and a evidence assessed, this food is not concentrations healthy cardiovascular sufficiently characterised for a system scientific assessment of this claimed effect and the claim could not therefore be substantiated. Dietary fibre helps to Non-compliance with the Regulation not validated 2010;8(10):1735 maintain normal blood because on the basis of the scientific sugar levels. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

749

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747

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Nucleotides

Art.13(1) Nucleotides

Dietary nucleotides are conditionally essential nutrients that provide building blocks for new cells. Dietary nucleotides: - promote general wellbeing [and/or] - enhance the bodys immunity [and/or] - help promote normal/proper digestive/intestinal function Dietary nucleotides enhance immune system function following exercise stress

Non-compliance with the Regulation immune defence because on the basis of the scientific against pathogens evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2066

Non-authorised

1626

Art.13(1) Nucleotides

Non-compliance with the Regulation immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Dietary nucleotides help Non-compliance with the Regulation Digestive function support a healthy gastro because on the basis of the scientific -intestinal tract. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1799

Non-authorised

1624

2011;9(6):2228

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Art.13(1) Rich in dietary fibre

Art.13(1) Fruits (fresh, frozen, canned, bottled, dried, juiced)

Art.13(1) Vegetable-rich diet

Art.13(1) Bromelain

Diets high in fibre help Non-compliance with the Regulation not validated 2010;8(10):1735 control your weight. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Diets rich in fruit Non-compliance with the Regulation not validated 2011;9(6):2245 promote heart health. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Diets rich in vegetables Non-compliance with the Regulation not validated 2011;9(6):2245 promote heart health. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Digestive aid, protein Non-compliance with the Regulation Improvement of the 2011;9(6):2228 digestion because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation.

Non-authorised

1416

Non-authorised

1212

Non-authorised

1428

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Papain

Digestive aid, protein digestion

Art.13(1) Christe marine

Art.13(1) Vitamin E

Non-compliance with the Regulation Improvement of the 2011;9(6):2228 because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation. Draineur naturel Non-compliance with the Regulation Increase in renal water 2010;8(10):1742 Dpuratif stimulant because on the basis of the scientific elimination l'limination de l'eau et evidence assessed, this claimed effect des toxines for this food is not a beneficial Clarification provided physiological effect as required by the C. maritimum is Regulation. depurative and diuretic Due to Vitamin E Non-compliance with the Regulation contribution to normal 2010;8(10):1816 favourable effects on because on the basis of the scientific cognitive function free radicals it could evidence assessed, this claimed effect support reducing the for this food has not been age related cognitive substantiated. decline.

Non-authorised

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Non-authorised

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Non-authorised

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Health relationship

EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Food with a reduced glycemic response

Due to its (modified) Non-compliance with the Regulation not validated carbohydrate because on the basis of the scientific composition, this food evidence assessed, this food is not has a lower blood sufficiently characterised for a glucose and insulin scientific assessment of this claimed response; effect and the claim could not therefore This food has a [x%] be substantiated. lower impact on blood sugar levels than comparable foods and thus helps to maintain more steady blood sugar levels graphical presentations of blood glucose response curves] Art.13(1) Carbohydrates that induce Due to its (modified) Non-compliance with the Regulation not validated a reduced glycaemic carbohydrate because on the basis of the scientific response composition, this food evidence assessed, this food is not has a lower blood sufficiently characterised for a glucose and insulin scientific assessment of this claimed response; This food has effect and the claim could not therefore a [x%] lower impact on be substantiated. blood sugar levels than comparable foods and thus helps to maintain more steady blood sugar levels;

2011;9(4):2082

Non-authorised

1122

2010;8(2):1491

Non-authorised

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Resveratrol

Art.13(1) Lutein/;Zeaxanthin

Art.13(1) EAS Creatine (EAS Phosphagen)

Due to its antioxidant Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 activity, resveratrol because on the basis of the scientific proteins and lipids from contributes to cell evidence assessed, this claimed effect oxidative damage protection from the for this food has not been damage caused by free substantiated. radicals. Provides antioxidant protection. Helps to scavenge free radicals which are responsible for skin aging. Helps to fight against skin aging thanks to its antioxidant activity. Due to the antioxidant Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 properties lutein/ because on the basis of the scientific proteins and lipids from zeaxanthin/ contributes evidence assessed, this claimed effect oxidative damage to the hindrance of for this food has not been harmful oxidative substantiated. processes in the body, in this way to the maintenance of our health/ to the defence of the tissues. EAS Creatine (EAS Non-compliance with the Regulation increase in endurance 2011;9(7):2303 Phosphagen) is because on the basis of the scientific capacity clinically tested to evidence assessed, this claimed effect improve anaerobic work for this food has not been capacity substantiated.

Non-authorised

1957

Non-authorised

1914

Non-authorised

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Art.13(1) EAS Phosphagen Elite

Art.13(1) EAS Phosphagen Elite

EAS Phosphagen Elite Non-compliance with the Regulation growth or maintenance 2011;9(6):2247 is clinically shown to because on the basis of the scientific of muscle mass boost muscular strength evidence assessed, this claimed effect EAS Phosphagen Elite for this food has not been is clinically shown to substantiated. increase strength by up to 15% EAS Phosphagen Elite is designed to boost overall muscular strength Boost muscular strength EAS Phosphagen Elite Non-compliance with the Regulation Increase in endurance 2011;9(6):2247 is clinically shown to because on the basis of the scientific capacity increase anaerobic evidence assessed, this claimed effect threshold EAS for this food has not been Phosphagen Elite is substantiated. clinically shown to increase physical working capacity at fatigue threshold

Non-authorised

1536

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Entry Id

Art.13(1) EAS Phosphagen Elite

Art.13(1) EAS Phosphagen Elite

EAS Phosphagen Elite Non-compliance with the Regulation Increase in endurance 2011;9(6):2247 is designed to provide a because on the basis of the scientific capacity higher quality workout, evidence assessed, this claimed effect and the addition of beta for this food has not been alanine appears to substantiated. enhance average training volume more so than creatine alone EAS Phosphagen Elite is clinically shown to result in greater training volume threshold EAS Phosphagen Elite Non-compliance with the Regulation increase in endurance 2011;9(6):2247 is designed to provide a because on the basis of the scientific performance higher quality workout, evidence assessed, this claimed effect and the addition of beta for this food has not been alanine appears to substantiated. enhance average training volume more so than creatine alone EAS Phosphagen Elite is clinically shown to result in greater training volume threshold

Non-authorised

1538

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Entry Id

Art.13(1) EAS Phosphagen HP

EAS Phosphagen HP Non-compliance with the Regulation Increase in 2011;9(6):2247 can help improve total because on the basis of the scientific performance during anaerobic work evidence assessed, this claimed effect intense and repeated performed EAS for this food has not been anaerobic exercise Phosphagen HP is substantiated. bouts clinically tested to help improve anaerobic work capacity EAS Phosphagen HP can help improve total anaerobic work performed Art.13(1) EAS Phosphagen HP EAS Phosphagen HP is Non-compliance with the Regulation growth or maintenance 2011;9(6):2247 clinically shown to because on the basis of the scientific of muscle mass increase strength evidence assessed, this claimed effect EAS Phosphagen HP is for this food has not been clinically shown to boost substantiated. muscular strength EAS Phosphagen HP is designed to boost overall muscular strength Art.13(1) Nuts - peanuts and tree Eating 30g of nuts per Non-compliance with the Regulation not validated 2011;9(4):2032 nuts (almonds, hazelnuts, day as part of a because on the basis of the scientific pecans, pistachios and balanced diet helps evidence assessed, this food is not walnuts), excluding brazil, maintain heart health. sufficiently characterised for a macadamia and cashew scientific assessment of this claimed nuts effect and the claim could not therefore be substantiated.

Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Nuts - peanuts and tree nuts (almonds, hazelnuts, pecans, pistachios and walnuts), excluding brazil, macadamia and cashew nuts

Eating 30g of nuts per Non-compliance with the Regulation not validated day as part of an energy because on the basis of the scientific restricted diet helps evidence assessed, this food is not maintain a healthy sufficiently characterised for a weigh scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Partially Hydrolysed Guar Eating a diet high in Non-compliance with the Regulation Reduction of postGum (PHGG) fiber can help control because on the basis of the scientific prandial glycaemic postprandial glucose evidence assessed, this claimed effect response levels and serum lipid for this food has not been profiles and promote substantiated. healthy triglyceride levels Dietary fiber helps improve glycemic control so you maintain normal blood sugar and insulin levels essential for good health PHGG helps to regulate plasma glucose levels and glycemic index of the foods after meals.

2011;9(4):2032

Non-authorised

1130

2010;8(2):1465

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Partially Hydrolysed Guar Eating a diet high in Non-compliance with the Regulation Increase in Satiety Gum (PHGG) fiber can help you because on the basis of the scientific control your weight evidence assessed, this claimed effect Eating a diet high in for this food has not been fiber can help you substantiated. maintain your weight by helping to curb your cravings. Diets rich in soluble fiber may help decrease feelings of hunger Art.13(1) Partially Hydrolysed Guar Eating a diet high in Non-compliance with the Regulation Maintenance or Gum (PHGG) fiber can help you because on the basis of the scientific achievement of a control your weight evidence assessed, this claimed effect normal body weight Eating a diet high in for this food has not been fiber can help you substantiated. maintain your weight by helping to curb your cravings. Diets rich in soluble fiber may help decrease feelings of hunger Art.13(1) Vegetables of 5 colors Eating a variety of Non-compliance with the Regulation "general health" colorful vegetables because on the basis of the scientific helps to protect your evidence assessed, this claimed effect health. Eating for this food is not sufficiently defined vegetables of all the to be able to be assessed and the available colors helps to claim could not therefore be get all the nutrients and substantiated. protective substances that will contribute to the wellbeing of your body.

2010;8(2):1465

Non-authorised

790

2010;8(2):1465

Non-authorised

790

2010;8(10):1738

Non-authorised

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Entry Id

Art.13(1) Food Category: Fish Food: Cultured Sea bass and Gilthead Sea bream Food Component / Nutrient: EPA & DHA Omega 3 Highly Unsaturated fatty acids

Art.13(1) Echium oil

Eating cultured sea Non-compliance with the Regulation maintenance of normal 2010;8(10):1796 bass and gilthead sea because on the basis of the scientific blood LDL-cholesterol bream twice a week, as evidence assessed, this claimed effect concentrations a rich source of omega- for this food has not been 3 highly unsaturated substantiated. fatty acids and part of a healthy lifestyle, has been shown to help maintain heart health Echium oil contains Non-compliance with the Regulation Reduction of 2011;9(4):2061 omega-3 fatty acid, because on the basis of the scientific inflammation stearidonic acid, which evidence assessed, this claimed effect is efficiently for this food is not a beneficial metabolized in the body physiological effect as required by the to anti-inflammatory n-3 Regulation. LC PUFA's, i.e. EPA and DPA. Echium oil contains omega-6 fatty acid, ylinoleic acid, which is efficiently metabolized in the body.

Non-authorised

1317

Non-authorised

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Entry Id

Art.13(1) Rapsl (einfach ungesttigte Fettsuren)

Einfach ungesttigte Fettsuren halten die Arterien elastisch. Clarification provided Monounsaturated fatty acids keep arteries elastic. Example of wording: Monounsaturated fatty acids improve blood lipid levels. Monounsaturated fatty acids have a positive effect on blood lipid levels. Monounsaturated fatty acids stabilize blood lipid levels. Monounsaturated fatty acids maintain HDL cholesterol at constant levels. Omega-6 fatty acids keep arteries elastic. Omega-6 fatty acids stabilize blood lipid levels. Omega-6 fatty acids improve blood lipid levels

Non-compliance with the Regulation Maintenance of normal 2011;9(4):2068 because on the basis of the scientific blood HDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

1408

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Rapsl (einfach ungesttigte Fettsuren)

Einfach ungesttigte Fettsuren halten die Arterien elastisch. Clarification provided Monounsaturated fatty acids keep arteries elastic. Example of wording: Monounsaturated fatty acids improve blood lipid levels. Monounsaturated fatty acids have a positive effect on blood lipid levels. Monounsaturated fatty acids stabilize blood lipid levels. Monounsaturated fatty acids maintain HDL cholesterol at constant levels. Omega-6 fatty acids keep arteries elastic. Omega-6 fatty acids stabilize blood lipid levels. Omega-6 fatty acids improve blood lipid levels

Non-compliance with the Regulation maintenance of normal 2011;9(4):2068 because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

1408

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Art.13(1) Galacto-oligosaccharides Energises your Non-compliance with the Regulation Increasing numbers of 2011;9(4):2061 immunity boosting because on the basis of the scientific gastro-intestinal bacteria evidence assessed, this claimed effect microorganisms Helps boost your body's for this food is not a beneficial self defence physiological effect as required by the Regulation.

Non-authorised

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Carbohydrate foods and beverages

Enhances / maximises glycogen stores. Carbohydrate before, during exercise improves endurance performance / perform for longer. Carbohydrate rich diets before exercise help elevate pre-exercise glycogen stores. Ingestion during exercise maintains blood glucose. Glucose is the bodys naturally preferred source of energy during intense exercise. Consumption in events as short as 1 hr improves exercise performance. Endurance capacity / time to exhaustion / delays fatigue. Carbohydrate loading can delay fatigue and benefits endurance and multiple sprint sports. Energy for endurance / fuel for your muscles. Carbohydrate before

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

1279

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and after exercise extends endurance time and work output more than either alone. Glycogen Sparing. Ingestion during exercise maintains blood glucose. Glucose is the bodys naturally preferred source of energy during intense exercise. Art.13(1) Probiotic strain: Enhances levels of Non-compliance with the Regulation not validated Bifidobacterium lactis W51 beneficial bacteria in the because on the basis of the scientific intestine evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Enhances levels of Non-compliance with the Regulation not validated Bifidobacterium lactis W52 beneficial bacteria in the because on the basis of the scientific (Formerly known as intestine evidence assessed, this food is not Bifidobacterium infantis sufficiently characterised for a W52) scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3002

2010;8(2):1470

Non-authorised

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Art.13(1) Probiotic strain: Lactobacillus salivarius W24

Enhances levels of Non-compliance with the Regulation not validated beneficial bacteria in the because on the basis of the scientific intestine evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Probiotic supplement: Enhances levels of Non-compliance with the Regulation not validated Winclove 500 beneficial bacteria in the because on the basis of the scientific intestine ;Enhances the evidence assessed, this food is not level of lactobacilli and sufficiently characterised for a bifidobacteria in the scientific assessment of this claimed intestine effect and the claim could not therefore be substantiated. Art.13(1) Caffeinated carbohydrate Enhances mental Non-compliance with the Regulation not validated containing energy drinks performance, reaction because on the basis of the scientific time, alertness, focus evidence assessed, this food is not and memory. sufficiently characterised for a Energises. Gives you scientific assessment of this claimed an energy boost. effect and the claim could not therefore Enhances mental be substantiated. energy. Enhances alertness quickly.

2010;8(2):1470

Non-authorised

2977

2010;8(2):1470

Non-authorised

2996

2011;9(4):2082

Non-authorised

1272

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus, Enhances natural Non-compliance with the Regulation not validated Bifidobacterium (BB46); immune response. because on the basis of the scientific Bifidobacterium Helps to strengthen the evidence assessed, this food is not (BB02),Bifidobacterium immune defences. sufficiently characterised for a Breve(Bbr8 LMG PHelps to strenghten the scientific assessment of this claimed 17501)CSL, Lactobacillus natural defences.Helps effect and the claim could not therefore Rhamnosus ATC C53103 to strenghten the body be substantiated. (LGG), Lactobacillus casei defences. Eneificially 101/37(Img P-17504), affects the intestinal Lactobacillus delbruekii sppmicroflora. Balances the bulgaricus AY/CSL (LMG intestinal microflora. P1 Enhances level o Art.13(1) L/cysteine Enhances resistance Non-compliance with the Regulation contribution to normal and stimulates the because on the basis of the scientific collagen formation growth of hair and nails. evidence assessed, this claimed effect / Hair and nails for this food has not been revitalizing agent substantiated. Art.13(1) L/cysteine Enhances resistance Non-compliance with the Regulation maintenance of normal and stimulates the because on the basis of the scientific hair growth of hair and nails. evidence assessed, this claimed effect / Hair and nails for this food has not been revitalizing agent substantiated. Art.13(1) L/cysteine Enhances resistance Non-compliance with the Regulation maintenance of normal and stimulates the because on the basis of the scientific nails growth of hair and nails. evidence assessed, this claimed effect / Hair and nails for this food has not been revitalizing agent substantiated.

2009;7(9):1247

Non-authorised

2948

2010;8(10):1795

Non-authorised

4685

2010;8(10):1795

Non-authorised

4685

2010;8(10):1795

Non-authorised

4685

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium infantis UCC35624

Enhances the bodys natural immune response.

Art.13(1) Biotin

Art.13(1) Colostrum bovin

Art.13(1) Anthocyanidines + proanthocyanidines

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a Helps positively scientific assessment of this claimed influence a healthy effect and the claim could not therefore immune system be substantiated. Ensures normal Non-compliance with the Regulation reduction of tiredness functioning of the bodys because on the basis of the scientific and fatigue organ tissues and evidence assessed, this claimed effect systems, particularly in for this food has not been old age - Stimulates substantiated. physical work capacities - Recommended in case of intense fatigue and during recovery Entretien l'nergie et le Non-compliance with the Regulation not validated tonus because on the basis of the scientific Renforce la vitalit evidence assessed, this food is not A utiliser en cas de sufficiently characterised for a fatigue passagre scientific assessment of this claimed effect and the claim could not therefore be substantiated. Especially for the eye Non-compliance with the Regulation not validated health of older people because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1094

2010;8(10):1728

Non-authorised

119

2011;9(4):2048

Non-authorised

1890

2011;9(4):2083

Non-authorised

1791

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Arginine

Essential amino acid that plays an important role in the immune system.

Art.13(1) Lysine

Essential amino acid, needed for the synthesis of proteins necessary for maintenance of the body/ body tissues (collagen, teeth, bones and muscles)/ body function. Increases absorption, action and fixation of calcium, essential for optimal muscle, bone and teeth.

Non-compliance with the Regulation Immune system 2011;9(4):2051 because on the basis of the scientific functions evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation Contribution to normal 2011;9(4):2063 because on the basis of the scientific protein synthesis evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1713

Non-authorised

609

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lysine

Art.13(1) L-tyrosine

Art.13(1) Essential Fatty Acids

Art.13(1) L-tyrosine

Essential amino acid, Non-compliance with the Regulation Increase in calcium needed for the because on the basis of the scientific absorption leading to synthesis of proteins evidence assessed, this claimed effect an increase in calcium necessary for for this food has not been retention maintenance of the substantiated. body/ body tissues (collagen, teeth, bones and muscles)/ body function. Increases absorption, action and fixation of calcium, essential for optimal muscle, bone and teeth. Essential component of Non-compliance with the Regulation Contribution to normal almost all proteins in the because on the basis of the scientific synthesis of body. evidence assessed, no quantitative catecholamines indication of the necessary daily intake, to obtain the beneficial effect, could be provided for this food. Essential fatty acids to Non-compliance with the Regulation Digestive function aid in digestive tract because on the basis of the scientific function. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Essential for the natural Non-compliance with the Regulation contribution to normal formation of dopamine, because on the basis of the scientific muscle function required for normal evidence assessed, this claimed effect muscle function and for this food has not been contraction substantiated.

2011;9(4):2063

Non-authorised

609

2011;9(6):2270

Non-authorised 1928 (expiry of transitional period 02/01/2014)

2011;9(6):2228

Non-authorised

692

2011;9(6):2270

Non-authorised

1929

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) magnsium

Essentiel la rgulation Non-compliance with the Regulation Maintenance of normal 2010;8(10):1807 de la pression artrielle because on the basis of the scientific blood pressure evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food. Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation anti-inflammatory 2011;9(4):2033 Olive Biophenols as it appears on because on the basis of the scientific properties product: evidence assessed, this claimed effect Description of food in termsA potent source of olive attributes to this food the property of of food legislation biophenols with antipreventing, treating or curing a human categories: Food inflammatory properties disease, or refers to such properties supplement Examples of any which is prohibited for foods. alternative wording that Was food on Irish market may be used in relation before 1st July 2007: No to claim: Olive biophenols can reduce inflammation related to Osteoarthritis and Rheumatoid arthritis Is claim a picture: No

Non-authorised

379

Non-authorised

1882

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Olive Biophenols

Exact wording of claim Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 as it appears on because on the basis of the scientific proteins and lipids from product: A potent evidence assessed, this claimed effect oxidative damage Description of food in termssource of antioxidant for this food has not been of food legislation biophenols for substantiated. categories: Food strengthening and supplement balancing of the immune system from Was food on Irish market free radicals Examples before 1st July 2007: No of any alternative wording that may be used in relation to claim: Olive biophenols are important for a balanced immune system. Antioxidant activity of olive biophenols for healthy and balanced immune system Is claim a picture: No

Non-authorised

1367

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Olive Biophenols

Exact wording of claim Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 as it appears on because on the basis of the scientific proteins and lipids from product: A potent evidence assessed, this claimed effect oxidative damage Description of food in termssource of olive for this food has not been of food legislation biophenols that have substantiated. categories: Food anti-UV damage supplement properties Examples of any Was food on Irish market alternative wording that before 1st July 2007: No may be used in relation to claim: Olive biophenols can help in repairing skin damage due to sun burn and UV rays Is claim a picture: No Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation not validated 2011;9(4):2082 Alfalfa Shoots as it appears on because on the basis of the scientific product: Alfalfa Shoots evidence assessed, this food is not Description of food in termsare naturally good for sufficiently characterised for a of food legislation your heart scientific assessment of this claimed categories: food not Is claim a picture: No effect and the claim could not therefore covered by specific food Clarification provided be substantiated. legislation Exact wording of claim as it appears on Was food on Irish market product: Alfalfa Shoots before 1st July 2007: Yes are naturally good for your heart Is claim a picture: No

Non-authorised

1878

Non-authorised

1361

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation not validated 2011;9(6):2244 Sqeez Wild Blueberry Juiceas it appears on because on the basis of the scientific Drink product: Blueberries evidence assessed, this food is not have a wide range of sufficiently characterised for a Description of food in termshealth benefits including scientific assessment of this claimed of food legislation anti-ageing properties effect and the claim could not therefore categories: food not and the maintenance of be substantiated. covered by specific food urinary tract and vision legislation health Is claim a picture: No Was food on Irish market before 1st July 2007: Yes Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Anti- aging properties 2011;9(6):2228 Sqeez Wild Blueberry Juiceas it appears on because on the basis of the scientific Drink product: Blueberries evidence assessed, this claimed effect have a wide range of for this food is not sufficiently defined Description of food in termshealth benefits including to be able to be assessed and the of food legislation anti-ageing properties claim could not therefore be categories: food not and the maintenance of substantiated. covered by specific food urinary tract and vision legislation health. Is claim a picture: No. Was food on Irish market before 1st July 2007: Yes

Non-authorised

1370

Non-authorised

1352

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Maintenance of urinary 2011;9(6):2228 Sqeez Wild Blurberry Juice as it appears on because on the basis of the scientific tract Drink product: Blueberries evidence assessed, this claimed effect have a wide range of for this food is not sufficiently defined Description of food in termshealth benefits including to be able to be assessed and the of food legislation anti-ageing properties claim could not therefore be categories: food not and the maintenance of substantiated. covered by specific food urinary tract and vision legislation health. Is claim a picture: No. Was food on Irish market before 1st July 2007: Yes Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation not validated 2011;9(6):2243 Brocco Shoots as it appears on because on the basis of the scientific product: Brocco Shoots evidence assessed, this food is not Description of food in termsnaturally boost your sufficiently characterised for a of food legislation immune system. scientific assessment of this claimed categories: food not Is claim a picture: No. effect and the claim could not therefore covered by specific food be substantiated. legislation Was food on Irish market before 1st July 2007: Yes

Non-authorised

1369

Non-authorised

1362

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: chocolate

Exact wording of claim Non-compliance with the Regulation protection of lipids from 2010;8(10):1792 as it appears on because on the basis of the scientific oxidative damage product: Cocoa beans evidence assessed, this claimed effect Description of food in termsnaturally contain for this food has not been of food legislation polyphenols. Cocoa substantiated. categories: food not polyphenols are known covered by specific food for their antioxidant legislation properties. Examples of any Was food on Irish market alternative wording that before 1st July 2007: Yes may be used in relation to claim: Cocoa flavonols show antioxidative effects and help protect the cells against oxidative stress,help protect you from radicals which cause cell damage, help strengthen our body's natural defences againist oxidative stress. Description of picture: A cocoa bean.

Non-authorised

1372

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Protection of DNA, 2011;9(4):2057 coffee Description of food as it appears on because on the basis of the scientific proteins and lipids from in terms of food legislation product: Coffee evidence assessed, this claimed effect oxidative damage categories: food not naturally contains for this food has not been covered by specific food antioxidants, that may substantiated. legislation Was food on support the body's Irish market before 1st July natural cell defences. 2007: Yes Examples of any alternative wording that may be used in relation to claim: Coffee is a major dietary source of antioxidants. Antioxidants from dietary sources: protect from free radicals which cause cell damage; protect body tissues, lipids, cells and DNA from oxidative damage; help strengthen the body's natural defences against oxidative stress. Is claim a picture: Yes Description of picture: A coffee bean

Non-authorised

4301

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: fermented dairy products

Exact wording of claim as it appears on product: Enhances Description of food in termsnatural resistance. of food legislation Strengthen your categories: food not immunity. covered by specific food Is claim a picture: No. legislation

Non-compliance with the Regulation Immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(4):2061

Non-authorised

1374

Was food on Irish market before 1st July 2007: Yes Art.13(1) Name of Food product: Exact wording of claim Folic Acid/ folate as it appears on product: Folate (Folic Description of food in termsAcid) helps keep of food legislation arteries healthy categories: food not Examples of any covered by specific food alternative wording that legislation may be used in relation to claim: Folate (Folic Was food on Irish market Acid) helps keep blood before 1st July 2007: No vessels healthy Folate promotes a healthy heart

Non-compliance with the Regulation function of blood because on the basis of the scientific vessels evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1213

Non-authorised

192

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Product-specific claim: sodium alginate, HCA and piperine

Exact wording of claim Non-compliance with the Regulation increase in satiety 2011;9(6):2246 as it appears on because on the basis of the scientific leading to a reduction in product: Helps manage evidence assessed, this claimed effect energy intake appetite and hunger. for this food has not been Examples of any substantiated. Description of food in termsalternative wording that of food legislation may be used in relation categories: food not to claim: Contributes to covered by specific food reduce the appetite/Can legislation help in the management of weight Was food on Irish market control/Promotes the before 1st July 2007: No feeling of fullness and satiety/Helps to fel full sooner/Helps to stay full longer/Assists weight management/Helps to reduce the appetite and inhibits conversion of carbohydrates to fats/Helps maintain a healthy level of appetite. Is claim a picture: No.

Non-authorised

1884

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Product-specific claim: Sodium alginate and ascophyllum nodosum

Exact wording of claim as it appears on product: Helps manage blood glucose and insulin levels. Description of food in termsExamples of any of food legislation alternative wording that categories: food not may be used in relation covered by specific food to claim: Reduces legislation heightened glycaemic index/Blunts glucose Was food on Irish market and insuin before 1st July 2007: No elevation/Reduces the glycaemic load of a meal/Helps maintain a normal blood glucose level as part of a healthy lifestyle/Contributes to normal blood glucose levels as part of a healthy lifestyle/Contributes to normal glucose/insulin metabolism/Helps control blood glucose levels/Supports maintenance of normal glucose levels. Is claim a picture: No.

Non-compliance with the Regulation reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated.

2011;9(6):2261

Non-authorised

1881

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Product-specific claim: Sodium alginate and ascophyllum nodosum

Exact wording of claim as it appears on product: Helps manage blood glucose levels. Examples of any Description of food in termsalternative wording that of food legislation may be used in relation categories: food not to claim: Reduces covered by specific food heightened glycaemic legislation index/Blunts glucose elevation/Reduces Was food on Irish market glycaemic load of a before 1st July 2007: No meal/Helps maintain a normal blood glucose level as part of a healthly lifestyle/Contributes to normal glucose metabolism/Helps control blood glucose levels/Supports maintenance of normal glucose levels.

Non-compliance with the Regulation reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated.

2011;9(6):2261

Non-authorised

1868

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Lentil & Bean Shoots

Exact wording of claim as it appears on product: Lentil & Bean Description of food in termsShoots naturally boost of food legislation your digestive system. categories: food not Is claim a picture: No. covered by specific food legislation

Non-compliance with the Regulation Digestive function because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

1357

Was food on Irish market before 1st July 2007: Yes Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation contribution to normal methylsulpony/methane as it appears on because on the basis of the scientific collagen formation (MSM) product: evidence assessed, this claimed effect Methylsulpony/methane for this food has not been Description of food in terms(MSM) helps in the substantiated. of food legislation maintenance of normal categories: Food keratin levels in hair, supplement skin and nails. Examples of any Was food on Irish market alternative wording that before 1st July 2007: No may be used in relation to claim: Methylsulpony/methane (MSM) helps in the maintenance of normal keratin levels in hair, skin and nails. Help keep your hair nails and skin healthy and strong. Is claim a picture: No

2010;8(10):1746

Non-authorised

1874

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: methylsulpony/methane (MSM)

Exact wording of claim Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 as it appears on because on the basis of the scientific hair product: evidence assessed, this claimed effect Methylsulpony/methane for this food has not been Description of food in terms(MSM) helps in the substantiated. of food legislation maintenance of normal categories: Food keratin levels in hair, supplement skin and nails. Examples of any Was food on Irish market alternative wording that before 1st July 2007: No may be used in relation to claim: Methylsulpony/methane (MSM) helps in the maintenance of normal keratin levels in hair, skin and nails. Help keep your hair nails and skin healthy and strong. Is claim a picture: No

Non-authorised

1874

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: methylsulpony/methane (MSM)

Exact wording of claim Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 as it appears on because on the basis of the scientific nails product: evidence assessed, this claimed effect Methylsulpony/methane for this food has not been Description of food in terms(MSM) helps in the substantiated. of food legislation maintenance of normal categories: Food keratin levels in hair, supplement skin and nails. Examples of any Was food on Irish market alternative wording that before 1st July 2007: No may be used in relation to claim: Methylsulpony/methane (MSM) helps in the maintenance of normal keratin levels in hair, skin and nails. Help keep your hair nails and skin healthy and strong. Is claim a picture: No

Non-authorised

1874

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Powerful protectors of 2011;9(6):2228 Sqeez Cranberry and as it appears on because on the basis of the scientific the stomach Orange Juice Drink, Sqeez product: More recently, evidence assessed, this claimed effect Light Cranberry Juice Drink emerging research for this food is not sufficiently defined suggests that to be able to be assessed and the Description of food in termscranberries may also be claim could not therefore be of food legislation powerful protectors of substantiated. categories: food not our health in other covered by specific food areas of the body, such legislation as the stomach, gums and even the heart. Was food on Irish market before 1st July 2007: Yes Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Powerful protectors of 2011;9(6):2215 Sqeez Cranberry Juice as it appears on because on the basis of the scientific our gums Drink product: More recently, evidence assessed, this claimed effect emerging research for this food is not sufficiently defined Description of food in termssuggests that to be able to be assessed and the of food legislation cranberries may also be claim could not therefore be categories: food not powerful protectors of substantiated. covered by specific food our health in other legislation areas of the body, such as the stomach, gums Was food on Irish market and even the heart. before 1st July 2007: Yes Is claim a picture: No.

Non-authorised

1368

Non-authorised

1365

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Total Dietary Fibre

Exact wording of claim as it appears on product: People who Description of food in termshave a diet high in fibre of food legislation / People who eat foods categories: food not high in fibre tend to covered by specific food have a healthy heart. legislation Is claim a picture: No. Was food on Irish market before 1st July 2007: Yes

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1735

Non-authorised

855

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Product-specific claim: sodium alginate and ulva

Exact wording of claim Non-compliance with the Regulation not validated as it appears on because on the basis of the scientific product: Seaweed fibres evidence assessed, this food is not support body sufficiently characterised for a Description of food in termsdetoxification scientific assessment of this claimed of food legislation Examples of any effect and the claim could not therefore categories: food not alternative wording that be substantiated. covered by specific food may be used in relation legislation to claim: Seaweed fibres rid toxins from the Was food on Irish market body/Seaweed fibres before 1st July 2007: No aid colonic health/Seaweed fibres protect the colon/ Seaweed fibres can detox the body/Seaweed fibres help maintain a healthy colon/Seaweed fibres promote healthy conditions in the colon Is claim a picture: No

2011;9(4):2083

Non-authorised

1873

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation contribution to the Low Calorie Sweetener / as it appears on because on the basis of the scientific maintenance or Table-top Sweetener product: Splenda can evidence assessed, this claimed effect achievement of a (Granular & tablets help with slimming as for this food has not been normal body weight sucralose based) part of a calorie substantiated. Description of food in termscontrolled diet. of food legislation Splenda is also suitable categories: food not for those following a low covered by specific food carbohydrate diet. In legislation Was food on France, 'peut contributer Irish market before 1st July a une reduction de 20 l'apport calorique quotidien' Examples of any alternative wording that may be used in relation to claim: Splenda low calorie sweetener can help to maintain a healthy body weight as part of a caloriecontrolled diet. Splenda low calorie sweetener helps to control calorie intake as part of a calorie controlled diet. Is claim a picture: No

2011;9(6):2229

Non-authorised

4299

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation maintenance of normal 2011;9(6):2229 Low Calorie Sweetener / as it appears on because on the basis of the scientific blood glucose Table-top Sweetener product: Suitable for evidence assessed, this claimed effect concentrations (Granular & tablets people with diabetes for this food has not been sucralose based) within their healthy substantiated. Description of food in termsdietary plan / as part of of food legislation a healthy diet and categories: food not lifestyle. covered by specific food Examples of any legislation Was food on alternative wording that Irish market before 1st July may be used in relation 20 to claim: Splenda has no effect on carbohydrate metabolism or short or long term blood glucose Splenda low calorie sweetener has no effect on short or long term blood glucose or insulin secretion Splenda can assist in blood glucose control Is claim a picture: No

Non-authorised

4298

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Product-specific claim: sodium alginate, n-acetyl cysteine and piperine

Exact wording of claim Non-compliance with the Regulation elimination of heavy as it appears on because on the basis of the scientific metals product: Supports body evidence assessed, this claimed effect detoxification Examples for this food has not been of any alternative substantiated. Description of food in termswording that may be of food legislation used in relation to claim: categories: food not Rids toxins from the covered by specific food body/Aids colonic legislation health/Protects the colon/Cleanses the Was food on Irish market body/Helps maintain a before 1st July 2007: No healthy colon/Promotes healthy conditions in the colon/Detoxes the body Is claim a picture: No

2011;9(6):2248

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EFSA opinion reference Commission regulation

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Entry Id

Art.13(1) Name of Food product: Cheese

Exact wording of claim Non-compliance with the Regulation decreasing potentially 2010;8(10):1767 as it appears on because on the basis of the scientific pathogenic gastroproduct: The Irish Dairy evidence assessed, this claimed effect intestinal Description of food in termsBoard is currently for this food has not been microorganisms of food legislation selling 3 probiotic substantiated. categories: food not cheese products covered by specific food commercially which legislation contain Lb. paracasei NFBC 338: Product: Was food on Irish market Medium Mature before 1st July 2007: Yes Cheddar under the Pilgrims Choice brand, UK Front of pack: Probiotic Cheddar Rear of pack: Medium probiotic is made using the culture: Lactobacillus paracasei NFBC 338 and it has a smooth and mellow taste. Enjoyed regularly, it will help maintain a healthy digestive system. For best results and full benefits of probiotic culture, consume cold. Product: Mature Cheddar under Tesco private label, UK, Healthy Living Range Front of pack: Probiotic Mature Cheddar helps

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

to ensure a healthy and balanced digestive system. Rear of pack: Lactobacillus paracasei in Tesco Probiotic cheese helps maintain a healthy digestive lifestyle and a balanced diet. To guarantee the benefits, this cheese should be eaten uncooked. Product: Dubliner Lite, Carbery Milk Products, Ireland Front of pack: Probiotic cheese Rear of pack: Probiotic Cultures help maintain a healthy digestive system. Examples of any alternative wording that may be used in relation to claim: Probiotic Culture Lactobacillus Paracasei NFBC 338 helps maintain a healthy digestive system. Probiotic Culture Lactobacillus Paracasei NFBC 338 helps ensure a healthy digestive lifestyle. Probiotic

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Entry Id

Culture Lactobacillus Paracasei NFBC 338 helps maintain a balanced digestive system. Is claim a picture: No

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Cheese

Exact wording of claim Non-compliance with the Regulation increasing numbers of 2010;8(10):1767 as it appears on because on the basis of the scientific gastro-intestinal product: The Irish Dairy evidence assessed, this claimed effect microorganisms Description of food in termsBoard is currently for this food is not a beneficial of food legislation selling 3 probiotic physiological effect as required by the categories: food not cheese products Regulation. covered by specific food commercially which legislation contain Lb. paracasei NFBC 338: Product: Was food on Irish market Medium Mature before 1st July 2007: Yes Cheddar under the Pilgrims Choice brand, UK Front of pack: Probiotic Cheddar Rear of pack: Medium probiotic is made using the culture: Lactobacillus paracasei NFBC 338 and it has a smooth and mellow taste. Enjoyed regularly, it will help maintain a healthy digestive system. For best results and full benefits of probiotic culture, consume cold. Product: Mature Cheddar under Tesco private label, UK, Healthy Living Range Front of pack: Probiotic Mature Cheddar helps

Non-authorised

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

to ensure a healthy and balanced digestive system. Rear of pack: Lactobacillus paracasei in Tesco Probiotic cheese helps maintain a healthy digestive lifestyle and a balanced diet. To guarantee the benefits, this cheese should be eaten uncooked. Product: Dubliner Lite, Carbery Milk Products, Ireland Front of pack: Probiotic cheese Rear of pack: Probiotic Cultures help maintain a healthy digestive system. Examples of any alternative wording that may be used in relation to claim: Probiotic Culture Lactobacillus Paracasei NFBC 338 helps maintain a healthy digestive system. Probiotic Culture Lactobacillus Paracasei NFBC 338 helps ensure a healthy digestive lifestyle. Probiotic

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Status

Entry Id

Culture Lactobacillus Paracasei NFBC 338 helps maintain a balanced digestive system. Is claim a picture: No

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: Cheese

Exact wording of claim Non-compliance with the Regulation healthy and balanced 2010;8(10):1767 as it appears on because on the basis of the scientific digestive system product: The Irish Dairy evidence assessed, this claimed effect Description of food in termsBoard is currently for this food is not sufficiently defined of food legislation selling 3 probiotic to be able to be assessed and the categories: food not cheese products claim could not therefore be covered by specific food commercially which substantiated. legislation contain Lb. paracasei NFBC 338: Product: Was food on Irish market Medium Mature before 1st July 2007: Yes Cheddar under the Pilgrims Choice brand, UK Front of pack: Probiotic Cheddar Rear of pack: Medium probiotic is made using the culture: Lactobacillus paracasei NFBC 338 and it has a smooth and mellow taste. Enjoyed regularly, it will help maintain a healthy digestive system. For best results and full benefits of probiotic culture, consume cold. Product: Mature Cheddar under Tesco private label, UK, Healthy Living Range Front of pack: Probiotic Mature Cheddar helps

Non-authorised

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

to ensure a healthy and balanced digestive system. Rear of pack: Lactobacillus paracasei in Tesco Probiotic cheese helps maintain a healthy digestive lifestyle and a balanced diet. To guarantee the benefits, this cheese should be eaten uncooked. Product: Dubliner Lite, Carbery Milk Products, Ireland Front of pack: Probiotic cheese Rear of pack: Probiotic Cultures help maintain a healthy digestive system. Examples of any alternative wording that may be used in relation to claim: Probiotic Culture Lactobacillus Paracasei NFBC 338 helps maintain a healthy digestive system. Probiotic Culture Lactobacillus Paracasei NFBC 338 helps ensure a healthy digestive lifestyle. Probiotic

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Culture Lactobacillus Paracasei NFBC 338 helps maintain a balanced digestive system. Is claim a picture: No Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 Triphala as it appears on because on the basis of the scientific proteins and lipids from product: Triphala is a evidence assessed, this claimed effect oxidative damage Description of food in termssource of antioxidant for this food has not been of food legislation Examples of any substantiated. categories: Food alternative wording that supplement may be used in relation to claim: Has Was food on Irish market antioxidant activies/ has before 1st July 2007: No antioxidant activity/ protection from free radicals which cause cell damage/protects cells and tissues from oxidative damage/helps strengthen the bodys natural defenses against oxidative stress/protective effects due to antioxidant/ contributes to the total antioxidant capacity of the body/ helps prevent oxidative damage/Helps reduce oxidative stress Is claim a picture: No

Non-authorised

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: gelatin & cystine

Exact wording of claim Non-compliance with the Regulation Maintenance of normal 2011;9(6):2228 as it appears on because on the basis of the scientific structure and product: gelatin, cystine evidence assessed, this claimed effect appearance of hair and Description of food in termssignificantly strengthens has not been linked to a function of the nails of food legislation hair, skin and nails body, as required by Article 13 of the categories: Food Examples of any Regulation. supplement alternative wording that may be used in relation Was food on Irish market to claim: Gelatin and before 1st July 2007: No cystine significantly increases hair diameter and the degree of hardness of finger and toe nails. Art.13(1) Name of Food product: Exact wording of claim Non-compliance with the Regulation Maintenance of 2011;9(6):2228 gelatin & cystine as it appears on because on the basis of the scientific structure and elasticity product: gelatin, cystine evidence assessed, this claimed effect of the skin Description of food in termssignificantly strengthens has not been linked to a function of the of food legislation hair, skin and nails body, as required by Article 13 of the categories: Food Examples of any Regulation. supplement alternative wording that may be used in relation Was food on Irish market to claim: Gelatin and before 1st July 2007: No cystine significantly increases hair diameter and the degree of hardness of finger and toe nails.

Non-authorised 1879 (expiry of transitional period 02/01/2014)

Non-authorised 1879 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Flavonoids from green tea, Exceptionally strong apple and onion organic antioxidant.

Art.13(1) Glutamine and glutamine peptide

Art.13(1) Glutamine and glutamine peptide

Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 because on the basis of the scientific content, and antioxidant evidence assessed, this claimed effect properties for this food is not a beneficial physiological effect as required by the Regulation. Extra dietary supply of Non-compliance with the Regulation faster restoration of 2011;9(6):2225 glutamine restores because on the basis of the scientific muscle glycogen stores plasma glutamine levels evidence assessed, this claimed effect after strenuous after metabolic for this food has not been exercise stress/contributes to gut substantiated. protein synthesis/help decrease permeability of gut cells/helps to replenish carbohydrate stores in the muscle and the liver Extra dietary supply of Non-compliance with the Regulation decreasing gut 2011;9(6):2225 glutamine restores because on the basis of the scientific permeability plasma glutamine levels evidence assessed, this claimed effect after metabolic for this food is not a beneficial stress/contributes to gut physiological effect as required by the protein synthesis/help Regulation. decrease permeability of gut cells/helps to replenish carbohydrate stores in the muscle and the liver

Non-authorised

1805

Non-authorised

701

Non-authorised

701

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine and glutamine peptide

Art.13(1) Lutein/zeaxanthin

Art.13(1) Zea mays L. ; Common name : Mas

Art.13(1) Fats

Extra dietary supply of Non-compliance with the Regulation gut protein synthesis 2011;9(6):2225 glutamine restores because on the basis of the scientific plasma glutamine levels evidence assessed, this claimed effect after metabolic for this food is not a beneficial stress/contributes to gut physiological effect as required by the protein synthesis/help Regulation. decrease permeability of gut cells/helps to replenish carbohydrate stores in the muscle and the liver Eye protection factor(s) Non-compliance with the Regulation maintenance of normal 2011;9(4):2039 because on the basis of the scientific vision evidence assessed, this claimed effect for this food has not been substantiated. Facilite la perte de Non-compliance with the Regulation contribution to the 2011;9(6):2246 poids en complment because on the basis of the scientific maintenance or de mesures dittiques. evidence assessed, this claimed effect achievement of a Help weight loss in for this food has not been normal body weight addition to dieting substantiated. Fats are necessary for Non-compliance with the Regulation normal absorption of fat 2011;9(6):2220 the absorption of fatbecause this claim is contrary to the -soluble vitamins soluble vitamins. general principles for health claims. The use of this claim is considered misleading as it contradicts generally accepted scientific advice, European, national and international authorities informing the consumer to reduce intake of this substance and would therefore convey a conflicting and confusing message to consumers.

Non-authorised

701

Non-authorised

1606

Non-authorised

2788

Non-authorised

670

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fats

Fats are needed to absorb fat solublevitamins

Non-compliance with the Regulation normal absorption of fat 2011;9(6):2220 because this claim is contrary to the -soluble vitamins general principles for health claims. The use of this claim is considered misleading as it contradicts generally accepted scientific advice, European, national and international authorities informing the consumer to reduce intake of this substance and would therefore convey a conflicting and confusing message to consumers.

Non-authorised

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei B21060*

Favorisce il riequilibrio Non-compliance with the Regulation Decreasing potentially 2010;8(10):1804 dellecosistema because on the basis of the scientific pathogenic gastrointestinale evidence assessed, this claimed effect intestinal Clarification provided for this food has not been microorganisms - contributes to the substantiated. rebalancing of intestinal microflora; - reduces gastrointestinal discomfort in Irritable Bowel Syndrome; - reduces gastrointestinal discomfort in functional disorders of the gut; - reduces gastrointestinal symptoms in Irritable Bowel Syndrome, especially in IBS-predominant diarrhea; - reduces gastrointestinal symptoms in functional disorders of the gut, especially in IBS-predominant diarrhea.

Non-authorised

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei B21060*

Favorisce il riequilibrio Non-compliance with the Regulation maintenance of a 2010;8(10):1804 dellecosistema because on the basis of the scientific normal intestinal transit intestinale evidence assessed, this claimed effect time Clarification provided for this food has not been - contributes to the substantiated. rebalancing of intestinal microflora; - reduces gastrointestinal discomfort in Irritable Bowel Syndrome; - reduces gastrointestinal discomfort in functional disorders of the gut; - reduces gastrointestinal symptoms in Irritable Bowel Syndrome, especially in IBS-predominant diarrhea; - reduces gastrointestinal symptoms in functional disorders of the gut, especially in IBS-predominant diarrhea.

Non-authorised

2959

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei B21060*

Favorisce il riequilibrio Non-compliance with the Regulation reducing gastrodellecosistema because on the basis of the scientific intestinal discomfort intestinale evidence assessed, this claimed effect Clarification provided for this food has not been - contributes to the substantiated. rebalancing of intestinal microflora; - reduces gastrointestinal discomfort in Irritable Bowel Syndrome; - reduces gastrointestinal discomfort in functional disorders of the gut; - reduces gastrointestinal symptoms in Irritable Bowel Syndrome, especially in IBS-predominant diarrhea; - reduces gastrointestinal symptoms in functional disorders of the gut, especially in IBS-predominant diarrhea.

2010;8(10):1804

Non-authorised

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus salivarius I1794

Art.13(1) Lactobacillus salivarius I1794

Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico. E' un coadiuvante nei disordini della mucosa intestinale. E' utile nella digestione del lattosio. Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico. E' un coadiuvante nei disordini della mucosa intestinale. E' utile nella digestione del lattosio.

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2858 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 2970 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Improved lactose because on the basis of the scientific digestion evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2970 (expiry of transitional period 02/01/2014)

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus salivarius I1794

Art.13(1) Lactobacillus gasseri P 17632

Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico. E' un coadiuvante nei disordini della mucosa intestinale. E' utile nella digestione del lattosio. Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico.

Non-compliance with the Regulation Reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2970 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2858 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 2956 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri P 17632

Art.13(1) Lactobacillus gasseri P 17632

Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico.

Non-compliance with the Regulation Improved lactose because on the basis of the scientific digestion evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2956 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2956 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri P 18137

Art.13(1) Lactobacillus gasseri P 18137

Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico.

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2858 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 2958 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Improved lactose because on the basis of the scientific digestion evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2958 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus gasseri P 18137

Art.13(1) Lactobacillus paracasei I1687

Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico.

Non-compliance with the Regulation Reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2958 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Decreasing potentially 2010;8(2):1470, because on the basis of the scientific pathogenic gastro2012;10(8):2858 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 2961 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei I1687

Art.13(1) Lactobacillus paracasei I1687

Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. Favorisce l'equilibrio dell'ecosistema intestinale. Regola la funzionalit intestinale, ripristinando la normale microflora. Influisce positivamente sul benessere dell'organismo. Ripristina la naturale microflora dopo trattamento antibiotico/antimicotico.

Non-compliance with the Regulation Improved lactose because on the basis of the scientific digestion evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(2):1470, 2012;10(8):2858

Non-authorised 2961 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(2):1470, 2012;10(8):2858

Non-authorised 2961 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei I1688

Favorisce l'equilibrio dell'ecosistema intestinale.Regola la funzionalit intestinale, ripristinando la normale microflora.Influisce positivamente sul benessere dell'organismo.Ripristin a la naturale microflora dopo trattamento antibiotico.E' utile nella digestione del lattosio. Favorisce l'equilibrio dell'ecosistema intestinale.Regola la funzionalit intestinale, ripristinando la normale microflora.Influisce positivamente sul benessere dell'organismo.Ripristin a la naturale microflora dopo trattamento antibiotico.E' utile nella digestione del lattosio.

Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, because on the basis of the scientific pathogenic gastro2012;10(8):2858 evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised 2963 (expiry of transitional period 02/01/2014)

Art.13(1) Lactobacillus paracasei I1688

Non-compliance with the Regulation Improved lactose because on the basis of the scientific digestion evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2963 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei I1688

Favorisce l'equilibrio dell'ecosistema intestinale.Regola la funzionalit intestinale, ripristinando la normale microflora.Influisce positivamente sul benessere dell'organismo.Ripristin a la naturale microflora dopo trattamento antibiotico.E' utile nella digestione del lattosio. Favorise le confort digestif A utiliser en cas de selles liquides Clarification provided Promotes gastrointestinal/bowel/g ut health/ Promotes gastrointestinal wellbeing. Helps to reduce gastrointestinal discomfort.

Non-compliance with the Regulation Reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2963 (expiry of transitional period 02/01/2014)

Art.13(1) Colostrum bovin

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2048

Non-authorised

1889

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fibersol-2

Fibersol-2 helps to maintain normal bowel Brand name Pinefiber in function. Japan (Chemical name in Fibersol-2 maintains Japan: Indigestible dextrin. intestinal regularity. Also called resistant dextrinFibersol-2 supports within the European Union) bowel function and gut comfort. Art.13(1) Fibersol-2 Fibersol-2 helps to Brand name manage blood glucose Pinefiber in levels after a meal. Japan Fibersol-2 helps to (Chemical name balance blood glucose in Japan: levels Indigestible Fibersol-2 helps to . control the rise in blood dextrin. glucose levels after a Also called meal. resistant dextrin within the European Union) Art.13(1) Fibre Fibre helps maintain a healthy digestion

Non-compliance with the Regulation Changes in bowel because on the basis of the scientific function evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2070

Non-authorised

797

Non-compliance with the Regulation reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated.

2011;9(4):2070

Non-authorised

796

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1735

Non-authorised

753

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fish oils / Omega 3 fatty acids

Fish oils / Omega-3 oils Non-compliance with the Regulation maintenance of normal from fish / EPA and because on the basis of the scientific LDL-cholesterol DHA may help to evidence assessed, this claimed effect concentrations control / regulate blood for this food has not been lipids / lipid profile Fish substantiated. oils / Omega-3 oils from fish / EPA and DHA help support a healthy heart Art.13(1) Fish protein Fish protein is Non-compliance with the Regulation not validated combination of because on the basis of the scientific substances for a evidence assessed, this food is not beautiful skin sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Flavonoids in cranberry Flavonoids are natural, Non-compliance with the Regulation not validated juice health-promoting because on the basis of the scientific antioxidants. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Citrus paradise (Common Flavonoids contained Non-compliance with the Regulation not validated Name : Grapefruit) within the Grapefruit because on the basis of the scientific contribute to the evidence assessed, this food is not microbial balance in the sufficiently characterised for a body organs and scientific assessment of this claimed tissues effect and the claim could not therefore be substantiated.

2009;7(9):1263

Non-authorised

528, 698

2011;9(4):2083

Non-authorised

651

2011;9(4):2082

Non-authorised

1804

2011;9(4):2082

Non-authorised

3324

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Honey

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) PROPOLIS Flavonoids contained Non-compliance with the Regulation not validated within the propolis because on the basis of the scientific contribute to the evidence assessed, this food is not microbial balance in the sufficiently characterised for a body organs and scientific assessment of this claimed tissues. effect and the claim could not therefore be substantiated. Art.13(1) Flavonoids from green tea, Flavonoids, especially Non-compliance with the Regulation contribution to the apple and onion catechins from green because on the basis of the scientific maintenance or tea, reduce the evidence assessed, this claimed effect achievement of a absorption of for this food has not been normal body weight carbohydrates by 25%. substantiated. Carbohydrates account for 49% of total energy. Thus the weight slimming effect is a total of 12%. Reduces visceral fat

Flavonoids contained within the honey contribute to the microbial balance in the body organs and tissues.

2011;9(6):2243

Non-authorised

1318

2010;8(10):1810

Non-authorised

1244

2011;9(6):2246

Non-authorised

1806

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Citrus paradisi (nazwa powszechnie stosowana:grejpfrut)

Art.13(1) Fluoride

Art.13(1) Folic Acid

Flawonoidy Non-compliance with the Regulation not validated 2011;9(4):2082 wyst?puj?ce w because on the basis of the scientific grejpfrucie przyczyniaj? evidence assessed, this food is not si? do zapewnienia sufficiently characterised for a rwnowagi scientific assessment of this claimed mikrobiologicznej w effect and the claim could not therefore narz?dach i tkankach be substantiated. Clarification provided Flawonoidy wyst?puj?ce w grejpfrucie przyczyniaj? si? do zapewnienia rwnowagi mikrobiologicznej w narz?dach i tkankach/ Flavonoids contained within the Grapefruit contribute to the microbial balance in the Fluoride supports the Non-compliance with the Regulation maintenance of bone 2009;7(9):1212 mineralisation of bones. because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Folic acid protects the Non-compliance with the Regulation maintenance of normal 2010;8(10):1760 eye because on the basis of the scientific vision Folic acid important for evidence assessed, this claimed effect the eye for this food has not been substantiated.

Non-authorised

3325

Non-authorised

371

Non-authorised

83

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cyamopsis tetragonolobus Food fibre (Cyamopsis Non-compliance with the Regulation maintenance or 2009;7(9):1287 (Guar) tetragonolobus) creates because on the basis of the scientific achievement of a a sustained feeling of evidence assessed, this claimed effect normal body weight fullness allowing control for this food has not been your body weight substantiated. Art.13(1) Glucosinolates Foods containing Non-compliance with the Regulation Immune 2011;9(4):2061 glucosinolates help because on the basis of the scientific function/immune strengthen our body's evidence assessed, this claimed effect system defences. for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Dietary fibre Foods high in fibre help Non-compliance with the Regulation not validated 2010;8(10):1735 you to feel full for longer because on the basis of the scientific to help maintain your evidence assessed, this food is not body weight. sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Cholesterol Foods low in cholesterol Non-compliance with the Regulation not validated 2011;9(4):2083 help manage blood because on the basis of the scientific cholesterol. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Pancreatic enzymes For a better digestive Non-compliance with the Regulation Improvement of the 2011;9(6):2228 process because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation.

Non-authorised

2428

Non-authorised

1566

Non-authorised

745

Non-authorised

624

Non-authorised

1781

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-carnosine

For a healthy heart

Art.13(1) Quercetin

Art.13(1) Daucus carota (Carrot)

Art.13(1) Wheat sprouts

Art.13(1) Beta-glucan (WGP)

Non-compliance with the Regulation maintenance of the because on the basis of the scientific normal cardiac function evidence assessed, this claimed effect for this food has not been substantiated. For cardiovascular Non-compliance with the Regulation Cardiovascular health because on the basis of the scientific system evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. For eye health Non-compliance with the Regulation maintenance of vision promotes maintenance because on the basis of the scientific of vision apparatus evidence assessed, this claimed effect functions Improves dark for this food has not been adaptation Strengthens substantiated. eye capillaries Reduces eye tiredness in case of vision exertion For eye health. Non-compliance with the Regulation maintenance of normal because on the basis of the scientific vision evidence assessed, this claimed effect for this food has not been substantiated. For immunity. Non-compliance with the Regulation Immune system Strengthens immunity. because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(4):2038

Non-authorised

1826

2011;9(4):2067

Non-authorised

1844

2009;7(9):1288

Non-authorised

2431

2011;9(6):2248

Non-authorised

2833

2011;9(6):2228

Non-authorised

1792

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Shark cartilage

Art.13(1) Methylsulfonylmethane (MSM)

Art.13(1) Quercetine

For joint health. For Non-compliance with the Regulation maintenance of joints supportive tissue health. because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. For joint maintenance Non-compliance with the Regulation maintenance of joints Helps maintain proper because on the basis of the scientific functioning of joints, evidence assessed, this claimed effect tendons and ligaments for this food has not been substantiated. For liver and kidney Non-compliance with the Regulation Liver, kidneys health. because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2009;7(9):1269

Non-authorised

1852

2009;7(9):1268

Non-authorised

1616

2011;9(4):2067

Non-authorised

1846

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Jerusalum artichoke

For pancreas health, fat Non-compliance with the Regulation maintenance or upper body. Stabilises because on the basis of the scientific achievement of a sugar metabolism, evidence assessed, this claimed effect normal body weight supports pancreas for this food has not been activity and substantiated. carbohydrate burning so that the desire for sweets and hunger feelings diminish. A sense of satiety is achieved with smaller meals. Jerusalem artichoke also supports the digestive system so that the stomach is calmed, food is well digested and one obtains a light feeling. Inulin together with other Helix Slim substances stabilises insulin secretion in the pancreas. This leads to stabilisation of sugar metabolism, which in turn helps to keep weight under control. Helix Slim brand.

2009;7(9):1292

Non-authorised

2820

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sea buckthorn oil

For skin health / wellbeing

Art.13(1) Anthocyanidines + proanthocyanidines

Art.13(1) Silicon

Art.13(1) Silicon

Non-compliance with the Regulation Skin health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. For stomach health Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. For stomach health. Non-compliance with the Regulation forming a protecting Sooths the stomach because on the basis of the scientific coat on the mucus Protects the stomachs evidence assessed, this claimed effect membrane of the mucous membranes. for this food is not a beneficial stomach physiological effect as required by the Regulation. For stomach health. Non-compliance with the Regulation neutralisation of gastric Sooths the stomach because on the basis of the scientific acid Protects the stomachs evidence assessed, this claimed effect mucous membranes. for this food is not a beneficial physiological effect as required by the Regulation.

2011;9(6):2228

Non-authorised

590

2011;9(4):2083

Non-authorised

1790

2011;9(6):2259

Non-authorised

345

2011;9(6):2259

Non-authorised

345

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fermented whey

Art.13(1) Quercetin

Art.13(1) Zea mays (Maize)

Art.13(1) Zea mays (Maize)

For stomach health. Non-compliance with the Regulation not validated Maintains a healthy gut because on the basis of the scientific bacteria population and evidence assessed, this food is not aids the metabolism. sufficiently characterised for a The (L+) lactic acid scientific assessment of this claimed resulting from effect and the claim could not therefore fermentation is a natural be substantiated. prebiotic and makes the metabolism more effective. For the health of the Non-compliance with the Regulation Mental state and nervous system and the because on the basis of the scientific performance brain evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. For the urogenital Non-compliance with the Regulation Increase in renal water system health ' kidneybecause on the basis of the scientific elimination activity improving, lightly evidence assessed, this claimed effect diuretic, disinfecting and for this food is not a beneficial anti-inflammatory effect physiological effect as required by the Regulation. For the urogenital Non-compliance with the Regulation Reduction of system health ' kidneybecause on the basis of the scientific inflammation activity improving, lightly evidence assessed, this claimed effect diuretic, disinfecting and for this food is not a beneficial anti-inflammatory effect physiological effect as required by the Regulation.

2010;8(2):1473

Non-authorised

1803

2011;9(4):2067

Non-authorised

1845

2011;9(4):2061

Non-authorised

2505

2011;9(4):2061

Non-authorised

2505

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cordyceps sinensis-fungus Free radicals larvae-mycelium neutralisation actions.

Art.13(1) Fructooligosaccharides from sucrose

Non-compliance with the Regulation antioxidant activity, 2010;8(10):1752 because on the basis of the scientific antioxidant content, and evidence assessed, this claimed effect antioxidant properties for this food is not a beneficial physiological effect as required by the Regulation. Fructooligosaccharides Non-compliance with the Regulation Changes in bowel 2011;9(4):2023 /oligofructose promote because on the basis of the scientific function intestinal health/ healthy evidence assessed, this claimed effect conditions in the colon for this food has not been Fructooligosaccharides/ substantiated. oligofructose improve digestive comfort Fructooligosaccharides/ oligofructose help maintain a healthy digestive system Fructooligosaccharides/ oligofructose improve bowel function Fructooligosaccharides/ oligofructose improve intestinal well-being

Non-authorised

4390

Non-authorised

778

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructooligosaccharides from sucrose

Fructooligosaccharides Non-compliance with the Regulation Reduction of gastro/oligofructose promote because on the basis of the scientific intestinal discomfort intestinal health/ healthy evidence assessed, this claimed effect conditions in the colon for this food has not been Fructooligosaccharides/ substantiated. oligofructose improve digestive comfort Fructooligosaccharides/ oligofructose help maintain a healthy digestive system Fructooligosaccharides/ oligofructose improve bowel function Fructooligosaccharides/ oligofructose improve intestinal well-being

2011;9(4):2023

Non-authorised

778

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructooligosaccharides from sucrose

Fructooligosaccharides Non-compliance with the Regulation decreasing potentially 2010;8(10):1809 /oligofructose stimulate because on the basis of the scientific pathogenic gastrothe growth of evidence assessed, this claimed effect intestinal Bifidobacteria in the for this food has not been microorganisms colon substantiated. Fructooligosaccharides/ oligofructose stimulate the growth of good digestive bacteria Bifidogenic fibres, Fibres with bifidus effect, bifido-active fibres Prebiotic fibres Fructooligosaccharides/ oligofructose beneficially affect the intestinal flora Fructooligosaccharides/ oligofructose stimulate the growth of beneficial bacteria in the intestine Fructooligosaccharides/ oligofructose contribute to a better balance of the intestinal microflora Fructooligosaccharides/ oligofru ctose support the vitality of healthy gut flora

Non-authorised

779

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructooligosaccharides from sucrose

Fructooligosaccharides Non-compliance with the Regulation increasing numbers of 2010;8(10):1809 /oligofructose stimulate because on the basis of the scientific gastro-intestinal the growth of evidence assessed, this claimed effect microorganisms Bifidobacteria in the for this food is not a beneficial colon physiological effect as required by the Fructooligosaccharides/ Regulation. oligofructose stimulate the growth of good digestive bacteria Bifidogenic fibres, Fibres with bifidus effect, bifido-active fibres Prebiotic fibres Fructooligosaccharides/ oligofructose beneficially affect the intestinal flora Fructooligosaccharides/ oligofructose stimulate the growth of beneficial bacteria in the intestine Fructooligosaccharides/ oligofructose contribute to a better balance of the intestinal microflora Fructooligosaccharides/ oligofru ctose support the vitality of healthy gut flora

Non-authorised

779

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructooligosaccharides from sucrose

Fructooligosaccharides/ Non-compliance with the Regulation increasing calcium oligofructose because on the basis of the scientific and/or magnesium enhance/promote/ evidence assessed, this claimed effect absorption leading to increase magnesium for this food has not been an increase in absorption substantiated. magnesium and/or Fructooligosaccharides/ calcium retention oligofructose enhance/promote/ increase magnesium absorption Fructooligosaccharides/ oligofructose support isoflavone activity on bone health Art.13(1) Omega 3-Fatty acids Function in the Non-compliance with the Regulation Anti-inflammatory containing synthesis of because on the basis of the scientific action eicosapentaenoic acid-EPAprostaglandins. evidence assessed, this claimed effect and docosahexaenoic acid Helps in inflammatory, attributes to this food the property of (DHA) rheumatismal disease. preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. Art.13(1) Gamma Linolenic acid GLA balances skin Non-compliance with the Regulation Maintenance of the (GLA) from Evening moisture content, keeps because on the basis of the scientific barrier function of the primrose Oil the skin smooth, evidence assessed, this claimed effect skin reduces itching, and for this food has not been soothes skin irritation. substantiated.

2011;9(4):2023

Non-authorised

777

2011;9(4):2078

Non-authorised

4688

2011;9(4):2059

Non-authorised

1554

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Gamma-linolenic acid (GLA)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

GLA can be used with Non-compliance with the Regulation Maintenance of cold hands and feet / because on the basis of the scientific peripheral blood flow inner support to evidence assessed, this claimed effect maintain hands and feet for this food has not been in good condition / helps substantiated. maintain a healthy peripheral blood circulation Borage oil (GLA= gamma GLA contributes to Non-compliance with the Regulation Maintenance of normal linolenic acid) maintenance of normal because on the basis of the scientific structure and skin cell structure and evidence assessed, this claimed effect appearance of the skin elasticity has not been linked to a function of the body, as required by Article 13 of the Regulation. GLA (example from BoragoGLA helps maintain Non-compliance with the Regulation Maintenance of the Officinalis, Primerose oil, your skin fresh and because on the basis of the scientific barrier function of the Blackcurramt seed oil) moist evidence assessed, this claimed effect skin for this food has not been substantiated. Gamma linolenic acid GLA supports weight Non-compliance with the Regulation Weight maintenance management GLA because on the basis of the scientific after weight loss reduces re-gaining evidence assessed, this claimed effect weight after dieting for this food has not been substantiated. Zinc carnosine Gastric comfort. Non-compliance with the Regulation reduction of gastroSupports a healthy because on the basis of the scientific intestinal discomfort gastric environment. evidence assessed, this claimed effect Zinc-carnosine supports for this food has not been the natural defenses substantiated. and healthy ecology of the gastric lining.

2010;8(2):1477

Non-authorised

638

2011;9(4):2059

Non-authorised 4296 (expiry of transitional period 02/01/2014)

2011;9(4):2059

Non-authorised

2065

2010;8(2):1477

Non-authorised

496

2011;9(6):2248

Non-authorised

1760

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Emblica officinalis FRUIT Gives strength and RIND energy. Helps build muscle.

Art.13(1) Glucomannan (Konjac)

Art.13(1) Glucomannan (Konjac)

Glucomannan: - helps to control/ balance blood insulin/ glucose level - can help to reduce the glycemic index of a meal - has beneficial effects on blood glucose and blood insulin level - is suitable for diabetics Glucomannan: -Helps to Non-compliance with the Regulation decreasing potentially 2010;8(10):1798 restore the intestinal because on the basis of the scientific pathogenic gastroflora -Has a prebiotic evidence assessed, this claimed effect intestinal effect -Helps to for this food has not been microorganisms stimulate the growth of substantiated. beneficial colon bacteria -Helps to stimulate the growth of Bifidobacteria -Helps to stimulate the growth of bacteria in the colon

Non-compliance with the Regulation growth or maintenance 2011;9(6):2247 because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation reduction of post2010;8(10):1798 because on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated.

Non-authorised

4038

Non-authorised

1559

Non-authorised

1558

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucosamine hydrochlorideGlucosamine helps to Non-compliance with the Regulation Maintenance of joints 2009;7(9):1264 maintain strong joints because on the basis of the scientific and connective tissues. evidence assessed, this claimed effect Naturally required by for this food has not been the body as building substantiated. blocks for connective tissues which are optimal for joint health and mobility. Connective tissues include cartilage which coats and cushions the bones in the joint. Synovial fluid bathes and lubricates the joints. Art.13(1) L-Glutamine Glutamine contributes Non-compliance with the Regulation maintenance of normal 2011;9(6):2225 to the healthy function because on the basis of the scientific neurological function of the nervous system evidence assessed, this claimed effect and the brain. for this food has not been substantiated. Art.13(1) L-Glutamine Glutamine helps Non-compliance with the Regulation integrity of the intestinal 2009;7(9):1235 promote and maintain because on the basis of the scientific lining and normal integrity of the intestinal evidence assessed, this claimed effect intestinal permeability lining. Glutamine may for this food has not been help prevent intestinal substantiated. permeability. Glutamine may help support a healthy gastro-intestinal tract.

Non-authorised 1565 (expiry of transitional period 02/01/2014)

Non-authorised

662

Non-authorised

1602

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

Art.13(1) Glutamine

Art.13(1) Glutamine

Art.13(1) Glutamine

Art.13(1) Glutamine

Glutamine is considered Non-compliance with the Regulation skeletal muscle tissue 2011;9(6):2225 essential for repair and because on the basis of the scientific repair recovery evidence assessed, this claimed effect Glutamine can aid In for this food has not been muscle tissue repair substantiated. Glutamine is the most Non-compliance with the Regulation Presence of a nutrient 2010;8(10):1743 abundant amino acid in because on the basis of the scientific in the human body the human body evidence assessed, the relationship Glutamine is the most between this food and health has not abundant free amino been defined, as required by the acid in human muscle Regulation. and plasma Glutamine may improve Non-compliance with the Regulation growth or maintenance 2011;9(6):2225 intestinal water and because on the basis of the scientific of muscle mass electrolyte absorption evidence assessed, this claimed effect Glutamine can help for this food has not been volumize muscle cells substantiated. Glutamine may increase cell swelling (volume) Glutamine may support Non-compliance with the Regulation faster restoration of 2011;9(6):2225 glucose homeostasis because on the basis of the scientific muscle glycogen stores during and after evidence assessed, this claimed effect after strenuous exercise for this food has not been exercise substantiated. Glutamine may support Non-compliance with the Regulation faster restoration of 2011;9(6):2225 muscle glycogen because on the basis of the scientific muscle glycogen stores replenishment evidence assessed, this claimed effect after strenuous followingexhaustive for this food has not been exercise exercise. substantiated.

Non-authorised

721

Non-authorised 720 (expiry of transitional period 02/01/2014)

Non-authorised

719

Non-authorised

723

Non-authorised

434

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-Glutamine

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation maintenance of 2011;9(6):2225 because on the basis of the scientific defence against evidence assessed, this claimed effect pathogenic gastrofor this food has not been intestinal substantiated. microorganisms Glutamine Non-compliance with the Regulation growth or maintenance 2011;9(6):2225 because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated. Anthocyanidines + Non-compliance with the Regulation not validated 2011;9(4):2083 proanthocyanidines because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Lycopene Good for the eye health Non-compliance with the Regulation maintenance of normal 2011;9(4):2031 of older people. because on the basis of the scientific vision evidence assessed, this claimed effect for this food has not been substantiated. Soy isoflavones + lycopeneGood for the prostate Non-compliance with the Regulation Prevention or treatment 2011;9(6):2228 + zinc + selenium + vitamin gland. because on the basis of the scientific of prostate cancer D + vitamin E + vitamin C A carefully considered evidence assessed, this claimed effect combination of attributes to this food the property of important isoflavones, preventing, treating or curing a human vitamins and minerals disease, or refers to such properties for mens well-being. which is prohibited for foods. Name of symbol included in the claim: MenBalans.

Glutamine supports a healthy digestive system and contributes to strengthen the natural defences Glutamine supports muscle cells Glutamine supports muscle protein metabolism Good for the cardiovascular system

Non-authorised

452

Non-authorised

722

Non-authorised

1787

Non-authorised

1827

Non-authorised

1859

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Citrullus lunatus (Watermelon) extract ACTI-08

Good source of Non-compliance with the Regulation protection of DNA, 2011;9(6):2246 antioxidants because on the basis of the scientific proteins and lipids from Contains naturally evidence assessed, this claimed effect oxidative damage occuring antioxidants for this food has not been Has antioxidant substantiated. properties Acts as an antioxidants Contributes to the protection against oxidation Helps increase the antioxidative capacity of the body Helps preventing oxidation Antioxidants help protect you from free radicals Antioxidants help protect your cells and tissues from oxidation Antioxidants contribute to the total antioxidant capacity of the body Antioxidants help to protect your body by reinforcing the body's natural defence against the effects of free radicals

Non-authorised

2244

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Grape juice

Art.13(1) Guava

Grape juice: Non-compliance with the Regulation protection of DNA, 2011;9(6):2246 - plays an important because on the basis of the scientific proteins and lipids from antioxidative function. evidence assessed, this claimed effect oxidative damage - helps to maintain a for this food has not been healthy cardiovascular substantiated. system. Guava is a major Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 dietary source of because on the basis of the scientific proteins and lipids from antioxidants evidence assessed, this claimed effect oxidative damage Antioxidants from for this food has not been dietary sources substantiated. contribute to the protection against free radicals which cause cell damage contributes to the protection of cells and tissues from oxidative damage help strengthen our body's natural defences against oxidative stress

Non-authorised

1197

Non-authorised

1258

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Guava

Art.13(1) Guava

Guava is a major dietary source of antioxidants/ Antioxidants from dietary sources contribute to the protection against free radicals which cause cell oxidation/ Contributes to the protection of cells and tissues from oxidation/ Help strengthen our body's natural defences against oxidative stress Guava is a major source of lycopene. Lycopene from dietary sources contributes to the maintenance of healthy skin.

Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

2263

Non-compliance with the Regulation protection of the skin because on the basis of the scientific from UV-induced evidence assessed, this claimed effect (including photofor this food has not been oxidative) damage substantiated.

2011;9(4):2031

Non-authorised

1259

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Guava

Art.13(1) Acacia gum (gum arabic)

Guava is a major Non-compliance with the Regulation protection of the skin 2011;9(4):2031 source of lycopene/ because on the basis of the scientific from UV-induced Lycopene from dietary evidence assessed, this claimed effect (including photosources contributes to for this food has not been oxidative) damage the maintenance of substantiated. healthy skin, when exposed to sun light (Avoid sunburns by using an effective sun screen. Lycopene is not a replacement for sun screens)/ helps to reduce skin reddening when exposed to sun light (Avoid sunburns by using an effective sun screen. Lycopene is not a replacement for sun screens) Gum acacia contributes Non-compliance with the Regulation Maintenance of normal 2010;8(2):1475 to lower the glycemix because on the basis of the scientific blood glucose response gum acacia evidence assessed, this claimed effect concentrations contribute to control for this food has not been blood glucose and substantiated. insuline levels gum acacia is suitable for diabetics diet gum acacia helps to reduce calorie intake

Non-authorised

2262

Non-authorised

842, 1977

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Acacia gum (gum arabic)

Art.13(1) HMB

Gum acacia contributes to lower the glycemix response gum acacia contribute to control blood glucose and insuline levels gum acacia is suitable for diabetics diet gum acacia helps to reduce calorie intake HMB can improve body adaptation to intense training

Non-compliance with the Regulation Reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect response for this food has not been substantiated.

2010;8(2):1475

Non-authorised

842, 1977

Art.13(1) HMB

Art.13(1) HMB

Art.13(1) HMB (B-hydroxy Bmethylbutyrate monohydrate)

Non-compliance with the Regulation increase in lean body because on the basis of the scientific mass evidence assessed, this claimed effect for this food has not been substantiated. HMB can improve body Non-compliance with the Regulation increase in muscle adaptation to intense because on the basis of the scientific strength training evidence assessed, this claimed effect for this food has not been substantiated. HMB can increase Non-compliance with the Regulation increase in lean body gains in lean body mass because on the basis of the scientific mass during resistance evidence assessed, this claimed effect training for this food has not been substantiated. HMB helps to enhance Non-compliance with the Regulation faster recovery from muscle energetics and because on the basis of the scientific muscle fatigue after recuperation. evidence assessed, this claimed effect exercise HMB helps with muscle for this food has not been energetics and substantiated. recuperation

2011;9(6):2227

Non-authorised

1583

2011;9(6):2227

Non-authorised

1583

2011;9(6):2227

Non-authorised

1582

2011;9(6):2227

Non-authorised

1576

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) HMB (B-hydroxy Bmethylbutyrate monohydrate)

Art.13(1) HMB and HMB/KIC combinations

HMB helps to reduce muscle protein breakdown following exercise Ingredient clinically shown to support protection of muscles from breakdown following exercise HMB helps to reduce exercise-induced muscle tissue breakdown. HMB increases muscle strength when taken during a resistance training program.

Non-compliance with the Regulation reduction of muscle because on the basis of the scientific tissue damage during evidence assessed, this claimed effect exercise for this food has not been substantiated.

2011;9(6):2227

Non-authorised

1577

Art.13(1) HMB (B-hydroxy Bmethylbutyrate monohydrate)

Art.13(1) HMB

Non-compliance with the Regulation increase in muscle 2011;9(6):2227 because on the basis of the scientific strength evidence assessed, this claimed effect for this food has not been substantiated. HMB may help increase Non-compliance with the Regulation increase in endurance 2011;9(6):2227 the onset of blood because on the basis of the scientific performance lactate accumulation evidence assessed, this claimed effect and VO2 peak. for this food has not been substantiated. HMB supplementation Non-compliance with the Regulation increase in endurance 2011;9(6):2227 aids aerobic metabolism because on the basis of the scientific performance in endurance athletes, evidence assessed, this claimed effect such as cyclists and for this food has not been runners substantiated.

Non-authorised

1587

Non-authorised

1580

Non-authorised

1581

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) HMB and HMB/KIC combinations

Art.13(1) HMB and HMB/KIC combinations

Art.13(1) HMB and HMB/KIC combinations

Art.13(1) HMB (B- hydroxy Bmethylbutyrate monohydrate)

HMB supplementation Non-compliance with the Regulation reduction of muscle can reduce muscle because on the basis of the scientific tissue damage during breakdown after intense evidence assessed, this claimed effect exercise training. for this food has not been HMB reduces the loss substantiated. of muscle proteins after intense training HMB supplementation Non-compliance with the Regulation skeletal muscle tissue maintains normal because on the basis of the scientific repair muscle repair after evidence assessed, this claimed effect training for this food has not been substantiated. HMB supplementation Non-compliance with the Regulation faster recovery from supports muscle because on the basis of the scientific muscle fatigue after recovery after training evidence assessed, this claimed effect exercise for this food has not been substantiated. HMB supports strength Non-compliance with the Regulation increase in muscle HMB has been shown because on the basis of the scientific strength to evidence assessed, this claimed effect increase strength. for this food has not been HMB has the ability to substantiated. enhance muscular strength Ingredient clinically shown to help boost strength Boost muscular strength

2011;9(6):2227

Non-authorised

1584

2011;9(6):2227

Non-authorised

1586

2011;9(6):2227

Non-authorised

1585

2011;9(6):2227

Non-authorised

1578

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Grapefrukt//Citrus paradisi Har en antioxidant (Common Name : effekt som kan skydda Grapefruit) kroppens celler. Antioxidant effect protecting bodys cells Art.13(1) Emblica officinalis FRUIT Has a gentle cleansing RIND action. Helps neutralise toxins

Non-compliance with the Regulation Protection of DNA, because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Non-compliance with the Regulation maintenance of normal because on the basis of the scientific bowel function evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Emblica officinalis FRUIT Has a gentle cleansing Non-compliance with the Regulation biotransformation of RIND action. Helps neutralise because on the basis of the scientific xenobiotic substances toxins evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Punica granatum FRUIT & Has significant Non-compliance with the Regulation protection of lipids from SEED antioxidant properties. because on the basis of the scientific oxidative damage Supports immunity. evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Sea buckthorn berry oil Healthy for the heart Non-compliance with the Regulation Cardiovascular health (cold-pressed) and blood vessels. because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(2):1489

Non-authorised

2188

2010;8(10):1733

Non-authorised

4039

2010;8(10):1733

Non-authorised

4039

2010;8(10):1750

Non-authorised

2123

2011;9(6):2228

Non-authorised

582

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sea buckthorn berry oil (cold-pressed)

Art.13(1) Sea buckthorn berry oil (cold-pressed)

Art.13(1) Chywanaprash

Healthy for the skin and Non-compliance with the Regulation Skin health 2011;9(6):2228 mucous membranes. because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Healthy for the Non-compliance with the Regulation Gut health 2011;9(6):2228 stomach. because on the basis of the scientific Protects the gut. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Healthy living A tonic for Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 healthy living Contains because on the basis of the scientific proteins and lipids from naturally occuring evidence assessed, this claimed effect oxidative damage antioxidants/antioxidant for this food has not been s help protect you from substantiated. radicals which cause cell damage/antioxidants help protect your cells and tissues from oxidative damage/ antioxidants contribute to the total antioxidant capacity of the body and m

Non-authorised

584

Non-authorised

585

Non-authorised

3315

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Brocoli : Dry extract of concentrated Brassica oleracea inflorescences juice

Art.13(1) Protein hydrolysate

Help in case of Non-compliance with the Regulation Reduction of gastric eructation. because on the basis of the scientific acid Regulating action on evidence assessed, this claimed effect gastric acidities/acidities for this food is not a beneficial of the stomach. physiological effect as required by the Protective role against Regulation. the gastric aggressions and their nuisances. Help promote healthy Non-compliance with the Regulation not validated blood sugar levels/can because on the basis of the scientific lower postprandial evidence assessed, this food is not blood sugar to normal sufficiently characterised for a levels/helps to regulate scientific assessment of this claimed sugar peaks after a effect and the claim could not therefore meal/helps improve be substantiated. blood glucose control/helps reduce plasma glucose levels/helps limit the post-prandial glucose rise

2011;9(6):2228

Non-authorised

2759

2011;9(4):2082

Non-authorised

1646

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Combination of Probiotics Help relieving intestinal (Lactobacillus helveticus discomfort Reinforce CNCM I-1722, the Intestinal Barrier, Lactobacillus rhamnosus Intestinal support for CNCM I-1720, travelers, Bifidobacterium longum Improve intestinal CNCM I-3470 and comfort in travellers, Saccharomyces cerevisiae Normalize intestinal boulardii ) transit

Art.13(1) Glucosamine sulphate

Non-compliance with the Regulation A combination of L. 2010;8(2):1470, because on the basis of the scientific rhamnosus CNCM I2012;10(8):2853 evidence assessed, this claimed effect 1720, L. helveticus for this food has not been CNCM I-1722, B. substantiated. longum subsp. longum CNCM I-3470 and S. cerevisiae var. boulardii CNCM I-1079 and defence against pathogenic gastrointestinal microorganisms Helpful for joints Non-compliance with the Regulation maintenance of normal 2011;9(6):2247 mobility, Helpful for because on the basis of the scientific bone structural and functional evidence assessed, this claimed effect maintaining, Building of for this food has not been joints surface, substantiated. ligaments, bones, blood vessel and skin, Contributes to preserve the structure and the elasticity grade of the cartilage.

Non-authorised 3017 (expiry of transitional period 02/01/2014)

Non-authorised

4672

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucosamine sulphate

Helpful for joints Non-compliance with the Regulation Maintenance of normal 2011;9(6):2247 mobility, Helpful for because on the basis of the scientific joints structural and functional evidence assessed, this claimed effect maintaining, Building of for this food has not been joints surface, substantiated. ligaments, bones, blood vessel and skin, Contributes to preserve the structure and the elasticity grade of the cartilage. Art.13(1) Omega 3 Long chain fatty Helps / contributes to / Non-compliance with the Regulation immune 2010;8(10):1799 acids promotes / supports the because on the basis of the scientific function/immune body's defence; evidence assessed, this claimed effect system stimulates the immune for this food is not sufficiently defined system. to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lactobacillus paracasei Helps balance the Non-compliance with the Regulation not validated 2009;7(9):1247 ssp. paracasei CRL-431 intestinal microflora because on the basis of the scientific (=L. casei 431) and Healthy bowel function evidence assessed, this food is not Lactobacillus acidophilus Helps improve bowel sufficiently characterised for a LA-5 function scientific assessment of this claimed Normalises bowel effect and the claim could not therefore movements/function be substantiated. Helps relieve gastrointestinal discomfort

Non-authorised 4672 (expiry of transitional period 02/01/2014)

Non-authorised

3658

Non-authorised

921

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic ingredient Lactobacillus casei F19 (LMG P-17806)

Art.13(1) L/carnitine

Helps beneficial bowel Non-compliance with the Regulation Bowel motor function 2009;7(9):1237 habit. Relieves bowel because on the basis of the scientific discomfort Helps evidence assessed, this claimed effect improve bowel function. for this food has not been Stabilises bowel transit. substantiated. Helps bowel regularity Supports the well-being of the gut. Promotes gastrointestinal wellbeing. Helps to reduce gastrointestinal discomfort. Helps burn fat faster Non-compliance with the Regulation increase in endurance 2011;9(6):2212 and thus improves because on the basis of the scientific capacity physical performance. / evidence assessed, this claimed effect Helpful in decreasing for this food has not been the LDL-colesterol level substantiated. / Helpful in decreasing colesterols blood levels / In diets, supplemented by a food diet and phisical exercices. / Accelerate the fatty acid import into mitochondria, which leads to a faster oxidation, favoring an efficient weight decrease as well as increasing of effort resistance.

Non-authorised

893

Non-authorised

4684

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L/carnitine

Helps burn fat faster Non-compliance with the Regulation maintenance of normal 2011;9(6):2212 and thus improves because on the basis of the scientific blood LDL-cholesterol physical performance. / evidence assessed, this claimed effect concentrations Helpful in decreasing for this food has not been the LDL-colesterol level substantiated. / Helpful in decreasing colesterols blood levels / In diets, supplemented by a food diet and phisical exercices. / Accelerate the fatty acid import into mitochondria, which leads to a faster oxidation, favoring an efficient weight decrease as well as increasing of effort resistance. Art.13(1) Apple cider vinegar Helps control and Non-compliance with the Regulation contribution to the 2011;9(6):2246 normalize body weight. because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated. Art.13(1) Fat-reduced cream powder Helps control blood Non-compliance with the Regulation maintenance of normal 2011;9(6):2246 [rich source of milk cholesterol; for people because on the basis of the scientific blood LDL-cholesterol sphingomyelin (a with elevated blood evidence assessed, this claimed effect concentrations sphingolipid)] cholesterol for this food has not been substantiated.

Non-authorised

4684

Non-authorised

1380

Non-authorised

3101

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Echium oil

Helps control levels of blood triglycerides

Art.13(1) Phoenix dactylifera (Date) Helps eliminate harmful substances from the body and ensures lively mind

Art.13(1) Eicosapentaenoic acid (EPA)

Helps improve appetite during recovery or recuperation.

Art.13(1) Carnitine

Helps improve muscle recovery after exercise -helps maintain optimal repair of muscle tissue -supports athletes in recovery from weight training -can help recreationally weight-trained in recovery from exercise -contributes to the reduction of muscle soreness from exercise in trained athletes

Non-compliance with the Regulation maintenance of normal 2009;7(9):1256 because on the basis of the scientific blood concentrations of evidence assessed, this claimed effect triglycerides for this food has not been substantiated. Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 because on the basis of the scientific content, and antioxidant evidence assessed, this claimed effect properties for this food is not a beneficial physiological effect as required by the Regulation. Non-compliance with the Regulation increase in appetite 2010;8(10):1736 because on the basis of the scientific after unintentional evidence assessed, this claimed effect weight loss leading to for this food has not been an increase in energy substantiated. intake Non-compliance with the Regulation faster recovery from 2011;9(6):2212 because on the basis of the scientific muscle fatigue after evidence assessed, this claimed effect exercise for this food has not been substantiated.

Non-authorised

548

Non-authorised

2475

Non-authorised

635

Non-authorised

1493

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carnitine

Art.13(1) Royal jelly

Helps improve muscle Non-compliance with the Regulation skeletal muscle tissue 2011;9(6):2212 recovery after exercise because on the basis of the scientific repair -helps maintain optimal evidence assessed, this claimed effect repair of muscle tissue for this food has not been -supports athletes in substantiated. recovery from weight training -can help recreationally weight-trained in recovery from exercise -contributes to the reduction of muscle soreness from exercise in trained athletes Helps in case of fatigue. Non-compliance with the Regulation not validated 2011;9(4):2083 Helps to support body's because on the basis of the scientific vitality. evidence assessed, this food is not Helps to make you feel sufficiently characterised for a more energetic. scientific assessment of this claimed Enhancement of effect and the claim could not therefore vitality/energy be substantiated.

Non-authorised

1493

Non-authorised

1231

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Branched chain amino acids

Helps in the repair and Non-compliance with the Regulation growth or maintenance 2010;8(10):1790 recovery of muscle because on the basis of the scientific of muscle mass tissue after exercise. evidence assessed, this claimed effect Helps muscle for this food has not been maintenance and substantiated. recovery following exercise. For the growth, development and maintenance of muscles and strength. For muscle building during training. Art.13(1) Caffeine and carbohydrate Helps increase Non-compliance with the Regulation increase in endurance 2011;9(6):2247 carbohydrate availability because on the basis of the scientific performance during endurance evidence assessed, this claimed effect exercise. for this food has not been Combination of caffeine substantiated. and carbohydrate improves endurance performance.

Non-authorised

445

Non-authorised

543

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Honey

Helps increase the Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 antioxidative capacity of because on the basis of the scientific proteins and lipids from the body 2. Has evidence assessed, this claimed effect oxidative damage antioxidant properties 3. for this food has not been Contains naturally substantiated. occuring antioxidants 4. Antioxidants help protect you from radicals which cause cell damage 5. Antioxidants contribute to the total antioxidant capacity of the body and help strenghthen our body's defences 6. Antioxidants help to protect our body by reinforcing the body's natural defence against the harmful effects of free radicals 7. Acts as an antioxidants 8.Good source of antioxidant 9.Show antioxidative activity and help protect against oxidative stress

Non-authorised

1321

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PROPOLIS

Helps increase the Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 antioxidative capacity of because on the basis of the scientific proteins and lipids from the body Has evidence assessed, this claimed effect oxidative damage antioxidant properties for this food has not been Contains naturally substantiated. occuring antioxidants Antioxidants help protect you from free radicals Antioxidants help protect your cells and tissues from oxidation Antioxidants contrib Art.13(1) Endothjelial (syn.: L-5Helps keep Non-compliance with the Regulation maintenance of normal 2011;9(6):2221 methyltetra-hydrofolic acid, arteries/blood vessels because on the basis of the scientific blood pressure calcium salt; Vitamin B9), healthy; evidence assessed, this claimed effect MetafolinTM Contributes to healthy for this food has not been arteries/ blood vessels; substantiated. Supports heart health by contributing to the normal functioning of the arteries/blood vessels; Helps maintain a normal blood pressure by supporting the elasticity of blood vessels/arteries.

Non-authorised

1243

Non-authorised

176

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hyaluronic Acid

Non-compliance with the Regulation maintenance of joints 2009;7(9):1266 because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Diosmin (a component of Helps maintain a good Non-compliance with the Regulation maintenance of 2011;9(6):2246 citrus peel extract and venous blood because on the basis of the scientific elasticity and strength precursor of diosmetin) circulation. evidence assessed, this claimed effect of the venous walls Supports a normal for this food has not been venous function. substantiated. Helps maintain healthy venous circulation in the legs. Protects veins from inflammatory reactions. Supports the strength of blood vessels. Art.13(1) Galactoligo-saccharide Helps maintain a Non-compliance with the Regulation decreasing potentially 2010;8(10):1809 (Arabino-galactans or Gum healthy balance of because on the basis of the scientific pathogenic gastroAcacia) beneficial bacteria evidence assessed, this claimed effect intestinal Promotes the positive for this food has not been microorganisms balance of the intestinal substantiated. flora maintains a healthy gut maintains a healthy intestinal environment Stimulates the growth of bifidobacteria

Helps keep mobility of joints. Helps to keep healthy joints.

Non-authorised

3132

Non-authorised

1908

Non-authorised

761

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Galactoligo-saccharide Helps maintain a Non-compliance with the Regulation increasing numbers of 2010;8(10):1809 (Arabino-galactans or Gum healthy balance of because on the basis of the scientific gastro-intestinal Acacia) beneficial bacteria evidence assessed, this claimed effect microorganisms Promotes the positive for this food is not a beneficial balance of the intestinal physiological effect as required by the flora maintains a Regulation. healthy gut maintains a healthy intestinal environment Stimulates the growth of bifidobacteria Art.13(1) Fructo-oligosaccharide Helps maintain a Non-compliance with the Regulation decreasing potentially 2011;9(6):2222 healthy balance of because on the basis of the scientific pathogenic gastrobeneficial bacteria, evidence assessed, this claimed effect intestinal Promotes the positive for this food has not been microorganisms balance of the intestinal substantiated. flora, Maintains a healthy gut, Maintains a healthy intestinal environment, Stimulates the growth of bifidobacteria Art.13(1) Lactobacillus gasseri PA Helps maintain a Non-compliance with the Regulation not validated 2009;7(9):1247 16/8, Bifidobacterium healthy gut flora. because on the basis of the scientific bifidum MF 20/5, evidence assessed, this food is not Bifidobacterium longum SP Helps to balance your sufficiently characterised for a 07/3 intestinal flora. scientific assessment of this claimed effect and the claim could not therefore Helps to protect the be substantiated. intestinal tract against harmful intestinal bacteria.

Non-authorised

761

Non-authorised

781

Non-authorised

933

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vaccinium macrocarpon, oxycoccus (Cranberry)

Helps maintain a Non-compliance with the Regulation Heart health healthy heart and blood because on the basis of the scientific vessels. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Brassica olaracea var Helps maintain a Non-compliance with the Regulation not validated italica (broccoli) healthy immune system. because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Whey protein peptides Helps maintain a Non-compliance with the Regulation not validated healthy vascular system because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Gamma-aminobutyric acid Helps maintain activity, Non-compliance with the Regulation cognitive function memory, perception of because on the basis of the scientific the environment, evidence assessed, this claimed effect particularly in the elderly for this food has not been Promotes mental substantiated. concentration Stimulates physical and mental capacities

2011;9(6):2215

Non-authorised

2499

2011;9(6):2243

Non-authorised

2844

2011;9(6):2243

Non-authorised

725

2009;7(9):1274

Non-authorised

1768

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Evening primrose oil and fish oil

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Helps maintain bone Non-compliance with the Regulation maintenance of normal strength/helps maintain because on the basis of the scientific bone bone density and evidence assessed, this claimed effect strength by increasing for this food has not been intestinal calcium substantiated. absorption and reducing urinary calcium excretion Apple cider vinegar Helps maintain healthy Non-compliance with the Regulation Skin health skin. because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Gamma-linolenic acid Helps maintain healthy Non-compliance with the Regulation Maintenance of joints (GLA; C18: 3n-6/C18: 3?6) supple and flexible, because on the basis of the scientific provided by evening mobile joints evidence assessed, this claimed effect primrose oil and/or borage for this food has not been (starflower) oil substantiated. Naringin (a component of Helps maintain Non-compliance with the Regulation Maintenance of bone citrus peel extract and healthy/strong bones because on the basis of the scientific precursor of naringenin) evidence assessed, this claimed effect for this food has not been substantiated. Hesperidin (a component ofHelps maintain Non-compliance with the Regulation Maintenance of bone citrus peel extract and healthy/strong bones (to because on the basis of the scientific precursor of hesperitin) be evaluated by EFSA) evidence assessed, this claimed effect (ingredient not found in the for this food has not been spanish food laws) substantiated.

2011;9(6):2224

Non-authorised

697

2011;9(6):2228

Non-authorised

1379

2010;8(2):1477

Non-authorised

494

2010;8(2):1493

Non-authorised

1907

2010;8(2):1493

Non-authorised

1764

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum HEAL 19 (DSM 15313 = 52A)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Gamma-linolenic acid Helps maintain joint Non-compliance with the Regulation Maintenance of joints (GLA) health/ supports joint because on the basis of the scientific flexibility /supports evidence assessed, this claimed effect mobility for this food has not been substantiated. Fish oil, omega 3 fatty Helps maintain joint Non-compliance with the Regulation maintenance of joints acids mobility and flexibility. because on the basis of the scientific Helps diminish morning evidence assessed, this claimed effect stiffness in joints. for this food has not been substantiated. Evening Primrose Oil Helps maintain joint Non-compliance with the Regulation maintenance of normal (EPO), Oenothera spp. andmobility. because on the basis of the scientific joints Fish Oil (FO) providing long evidence assessed, this claimed effect chain omega 6 and omega for this food has not been 3 fatty acids [gammasubstantiated. linolenic acid (GLA) and eicosapentaenoic acid (EPA)] Omega-3 fatty acids, Helps maintain mobility Non-compliance with the Regulation maintenance of joints DHA/EPA, Marine oils suchand flexibility of because on the basis of the scientific as fish oil, cod liver oil joints/helps diminish evidence assessed, this claimed effect containing DHA and EPA morning stiffness in for this food has not been joints/ helps maintain substantiated. healthy, flexible, mobile and supple joints

Helps maintain insulin sensitivity Helps to maintain a normal vaginal flora Supports a healthy intestinal flora

2009;7(9):1247

Non-authorised

1072

2010;8(2):1477

Non-authorised

637

2009;7(9):1263

Non-authorised

507

2011;9(6):2247

Non-authorised

696

2009;7(9):1263

Non-authorised

503

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hesperidin (a component ofHelps maintain normal citrus peel extract and blood cholesterol precursor of hesperitin) levels/Supports heart (ingredient not found in the health (to be evaluated spanish food laws) by EFSA). Art.13(1) Beta sitosterol Helps maintain normal kidney and prostate function

Art.13(1) Gamma-linolenic acid Helps maintain normal, (GLA; C18: 3n-6/C18: 3?6) healthy skin. provided by evening primrose oil and/or borage (starflower) oil Art.13(1) Gamma-linolenic acid Helps maintain optimal (GLA) comfort during menstrual cycle

Art.13(1) Tyrosine

Helps maintain physical and mental concentration in cases of temporary stress

Non-compliance with the Regulation maintenance of normal because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Non-compliance with the Regulation maintenance of normal because on the basis of the scientific prostate size and evidence assessed, this claimed effect normal urination for this food has not been substantiated. Non-compliance with the Regulation Maintenance of the because on the basis of the scientific barrier function of the evidence assessed, this claimed effect skin for this food has not been substantiated. Non-compliance with the Regulation Reduction of menstrual because on the basis of the scientific discomfort evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation increased attention because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2246

Non-authorised

1763

2010;8(10):1813

Non-authorised

1467

2011;9(4):2059

Non-authorised

499

2011;9(4):2059

Non-authorised

640

2011;9(6):2270

Non-authorised

1672

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-tryptophan

Helps maintain positive mood and good cognitive functions. L-tryptophane is a natural precursor of serotonin. L-tryptophane participates in the synthesis of serotonin, which is essential for the maintenance of emotional balance and serenity. Contributes to optimal relaxation. Helps to support the relaxation, mental and physical wellbeing. Contributes to maintain a normal healthy sleep.

Non-compliance with the Regulation Contribution to normal 2011;9(4):2073 because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

596

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-tryptophan

Helps maintain positive mood and good cognitive functions. L-tryptophane is a natural precursor of serotonin. L-tryptophane participates in the synthesis of serotonin, which is essential for the maintenance of emotional balance and serenity. Contributes to optimal relaxation. Helps to support the relaxation, mental and physical wellbeing. Contributes to maintain a normal healthy sleep.

Non-compliance with the Regulation Enhancement of mood 2011;9(4):2073 because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

596

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-tryptophan

Helps maintain positive Non-compliance with the Regulation Maintenance of normal 2011;9(4):2073 mood and good because on the basis of the scientific sleep cognitive functions. evidence assessed, this claimed effect L-tryptophane is a for this food has not been natural precursor of substantiated. serotonin. L-tryptophane participates in the synthesis of serotonin, which is essential for the maintenance of emotional balance and serenity. Contributes to optimal relaxation. Helps to support the relaxation, mental and physical wellbeing. Contributes to maintain a normal healthy sleep. Art.13(1) Docosahexaenoic acid Helps maintain sperm Non-compliance with the Regulation maintenance of normal 2010;8(10):1734 (DHA) motility because on the basis of the scientific spermatozoa motility helps maintain a healthy evidence assessed, this claimed effect male reproductive for this food has not been system substantiated. Art.13(1) Long chain Omega 3 fatty Helps maintain supple Non-compliance with the Regulation maintenance of joints 2009;7(9):1263 acids (EPA/DPA/DHA) and flexible joints because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

596

Non-authorised

628

Non-authorised

511

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Oenothera biennis Helps maintain supple Non-compliance with the Regulation Maintenance of joints 2010;8(2):1477 (Common Name : Evening and flexible joints because on the basis of the scientific Primrose) evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Pomegranate Juice Helps maintain the Non-compliance with the Regulation maintenance of normal 2010;8(10):1750 phenolic compounds cholesterol and lipids because on the basis of the scientific blood cholesterol (anthocyanins, tannines, levels. evidence assessed, this claimed effect concentrations ellagic acid) for this food has not been substantiated.

Non-authorised

2098

Non-authorised

1320

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Honey (as defined by The Helps maintain your Non-compliance with the Regulation not validated Honey Regulations 2003 natural defences. because on the basis of the scientific (as amended)) Honey antioxidants evidence assessed, this food is not contribute to the total sufficiently characterised for a antioxidative capacity of scientific assessment of this claimed the body. effect and the claim could not therefore Honey contains be substantiated. naturallyoccurring antioxidants. Honey helps to support the digestion with a natural antimicrobial action. Honey helps contribute to the natural defences of the body. Honey helps to support the digestion. Honey polyphenols help ensure our antioxidant capacity. Honey has a natural antimicrobial action.

2011;9(6):2243

Non-authorised

1159

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein (Marigold Extract)

Helps maintaining Non-compliance with the Regulation Maintenance of normal healthy eye function. because on the basis of the scientific vision. Oral supplementation of evidence assessed, the evidence Lutein and Zeaxanthin provided is insufficient to substantiate helps increasing this claimed effect for this food. macular pigment levels in plasma and retina. Oral supplementation with lutein results in increase in concentration of lutein in serum and macular pigment Helps enhance visual acuity in persons with compromised visual function Helps improve visual performance in persons with compromised visual function Art.13(1) Vitamin E Helps memory and Non-compliance with the Regulation contribution to normal perception retention, because on the basis of the scientific cognitive function especially in the elderly. evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Branched chain amino Helps muscle recovery Non-compliance with the Regulation faster recovery from acids (Leucine, Isoleucine, supports muscle fatigue because on the basis of the scientific muscle fatigue after valine) recovery evidence assessed, this claimed effect exercise for this food has not been substantiated.

2010;8(2):1492, 2012;10(6):2716

Non-authorised 1603 (expiry of transitional period 02/01/2014)

2010;8(10):1816

Non-authorised

183

2010;8(10):1790

Non-authorised

1478

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Branched chain amino Helps muscle recovery Non-compliance with the Regulation growth or maintenance acids (Leucine, Isoleucine, supports muscle fatigue because on the basis of the scientific of muscle mass valine) recovery evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Branched chain amino Helps muscle Non-compliance with the Regulation faster recovery from acids (Leucine, Isoleucine, recovery/supports because on the basis of the scientific muscle fatigue after valine) muscle fatigue recovery evidence assessed, this claimed effect exercise for this food has not been substantiated. Art.13(1) Meso-zeaxanthin (derived Helps optimising Non-compliance with the Regulation Maintenance of vision form lutein of plant extract healthy eye functions because on the basis of the scientific like marigold ,spinach evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Punica granatum FRUIT & Helps stimulate Non-compliance with the Regulation increase in appetite SEED appetite. because on the basis of the scientific after unintentional Helps stimulate appetite evidence assessed, this claimed effect weight loss leading to without problem for for this food has not been an increase in energy people with tendency to substantiated. intake acid stomach. Helps maintain the integrity of the lining of stomach and intestines. Art.13(1) Lactobacillus reuteri DSM Helps strengthen your Non-compliance with the Regulation not validated 17938 Lactobacillus reuteri body's natural defences because on the basis of the scientific ATCC PTA 5289 Stimulates the immune evidence assessed, this food is not system sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1790

Non-authorised

1478

2010;8(10):1790

Non-authorised

684

2010;8(2):1483

Non-authorised

2096

2010;8(10):1750

Non-authorised

2122

2009;7(9):1247

Non-authorised

1088

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Galacto-oligosaccharides Helps support a healthy Non-compliance with the Regulation Increasing numbers of 2011;9(4):2061 immune system in an because on the basis of the scientific gastro-intestinal ageing population evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

762

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein

Helps support eye Non-compliance with the Regulation Maintenance of vision 2010;8(2):1492, health Helps maintain because on the basis of the scientific 2012;10(6):2716 healthy eyes Nutrition evidence assessed, the evidence for eyes Promotes provided is insufficient to substantiate healthy eye this claimed effect for this food. function/helps maintain macular and retinal health Is one (of the) constituent(s) of the retina and the lens Is deposited naturally in the eye Is a constituent of the macular pigment Is highly and selectively accumulated in the retina Is highly and selectively accumulated in the macula lutea Contributes to macular pigment Fortifies the macula Important for the macula density Helps protect the retina and lens from oxidation (AFSSA) Helps protect the retina and lens from oxidative stress Natural antioxidant for the eye Helps fight free radicals in the eye

Non-authorised 1604 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zeaxanthin ( from marigold/Helps support eye Non-compliance with the Regulation maintenance of normal 2010;8(10):1724 capsicum extract / health helps maintain because on the basis of the scientific vision wolfberries fruit. healthy eyes nutrition evidence assessed, this claimed effect for eye promotes for this food has not been healthy eye function substantiated. helps maintain macular and retinal health is one(of the) constituent(s) of the retina and the lens/is deposited naturally in the eye is a constituent of the macular pigment is highly and selectively accumulated in the retina is highly and selectively accumulated in the macula lutea contributes to macular pigment/fortifies the macula important for the macula density helps protect the retina and lens from oxidation (AFSSA) helps protect the retina and lens from oxidative stress natural antioxidant for the eye helps fight free radicals in the eye natural filter of visible blue light natural filter of high-

Non-authorised

2169

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

energy, harmful blue light helps protect the eye against visible light damage helps protect the eye against harmful effects of light exposure Zeaxanthin als Bestandteil des makulren Pigments sorgt fr die Gesundheit der Makula lutea. Zeaxanthin wirkt wie eine innere Sonnenbrille. Zeaxanthin untersttzt das antioxidative Schutzsystem im Auge. Art.13(1) 2 - Dimethylaminoethanol Helps support mental Non-compliance with the Regulation Mental energy hydrogentartrate development because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

1530

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein

Helps support skin Non-compliance with the Regulation protection of the skin health /helps promote because on the basis of the scientific from UV-induced healthy skin /helps evidence assessed, this claimed effect (including photomaintain healthy skin for this food has not been oxidative) damage /helps to maintain your substantiated. skins healthy look and feel /is deposited naturally in the skin /is a natural compound contained in the dermis and epidermis /is a natural compound contained in the deepest layers of the skin /nutrition for skin /helps maintain skin moisture /helps maintain skin hydration /improves skin moisture /helps improve skin hydration /helps improve skin elasticity /supports skin elasticity /contributes to the appearance of skin associated with premature aging /helps protect the dermis and epidermis from oxidative stress /natural antioxidant for the skin /natural antioxidant for

2011;9(4):2030

Non-authorised

1605

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) MGN-3 Rice Bran Arabinoxylan compound

healthy skin /helps fight free radicals in the skin / Contributes to the maintenance of healthy skin when exposed to sun light (Avoid sunburns by using an effective sun screen. Beta carotene is not a replacement for sun screens) Helps the body maintain Non-compliance with the Regulation Stimulation of natural a strong immune because on the basis of the scientific killer cell activity system evidence assessed, this claimed effect Supports optimal for this food is not a beneficial immune functions physiological effect as required by the Regulation.

2011;9(6):2228

Non-authorised

3153

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carnitine

Helps the energy Non-compliance with the Regulation faster recovery from production in the cell by because on the basis of the scientific muscle fatigue after transporting fatty acids evidence assessed, this claimed effect exercise in places where they for this food has not been are used and substantiated. metabolised -contributes to the fat burning during exercise -contributes to increased fat oxidation -is important for the oxidation of fat -helps improve muscle recovery after exercise -helps maintain optimal repair of muscle tissue -plays an important role in lipid metabolism -can support lipid metabolism converts fatty acids into energy -helps to increase fatty acid oxidation in healthy humans

2011;9(6):2212

Non-authorised

1492

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carnitine

Helps the energy Non-compliance with the Regulation skeletal muscle tissue 2011;9(6):2212 production in the cell by because on the basis of the scientific repair transporting fatty acids evidence assessed, this claimed effect in places where they for this food has not been are used and substantiated. metabolised -contributes to the fat burning during exercise -contributes to increased fat oxidation -is important for the oxidation of fat -helps improve muscle recovery after exercise -helps maintain optimal repair of muscle tissue -plays an important role in lipid metabolism -can support lipid metabolism converts fatty acids into energy -helps to increase fatty acid oxidation in healthy humans

Non-authorised

1492

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carnitine

Helps the energy Non-compliance with the Regulation faster recovery from production in the cell by because on the basis of the scientific muscle fatigue after transporting fatty acids evidence assessed, this claimed effect exercise in places where they for this food has not been are used and substantiated. metabolised/contributes to the fat burning during exercise/contributes to increased fat oxidation/is important for the oxidation of fat/helps improve muscle recovery after exercise/helps mantain optimal repair of muscle tissue/transports longchain fatty acids into the mitocondria/plays an important role in lipid metabolism/can support lipid metabolism converts fatty acids into energy/turns fat into energy/helps to increase fatty acid oxidation in healty humans.

2011;9(6):2212

Non-authorised

738

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carnitine

Helps the energy Non-compliance with the Regulation skeletal muscle tissue 2011;9(6):2212 production in the cell by because on the basis of the scientific repair transporting fatty acids evidence assessed, this claimed effect in places where they for this food has not been are used and substantiated. metabolised/contributes to the fat burning during exercise/contributes to increased fat oxidation/is important for the oxidation of fat/helps improve muscle recovery after exercise/helps mantain optimal repair of muscle tissue/transports longchain fatty acids into the mitocondria/plays an important role in lipid metabolism/can support lipid metabolism converts fatty acids into energy/turns fat into energy/helps to increase fatty acid oxidation in healty humans.

Non-authorised

738

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PROPOLIS

Helps the natural Non-compliance with the Regulation not validated defences because on the basis of the scientific Contributes to a normal evidence assessed, this food is not immune response sufficiently characterised for a Support the immune scientific assessment of this claimed systems effect and the claim could not therefore Contributes to the be substantiated. natural defences Maintenance of the normal immune system Supports the natural resistance Contributes to natural immunological defences Propolis contributes to the natural defences and proper functioning of the immune system.

2010;8(10):1810

Non-authorised

1248

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L/arginine

Art.13(1) PROPOLIS

Art.13(1) AMORPHOPHALLUS KONJAC KOCH

Helps the organism to Non-compliance with the Regulation growth or maintenance 2011;9(4):2051 maintain and to recover because on the basis of the scientific of muscle mass after prolonged physical evidence assessed, this claimed effect effort. / Helps in for this food has not been muscular atrophy. / substantiated. Invigorator of the muscle mass. / Helps in the harmonious growth and development of the young organisms. / Helps to stimulate the production of Human Growth Hormone. / Helps in the development of the muscle mass. Helps the physiological Non-compliance with the Regulation not validated 2010;8(10):1810 blood fluidity because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Helps the physiological Non-compliance with the Regulation maintenance of normal 2010;8(10):1798 sugars balance. because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

4681

Non-authorised

3526

Non-authorised

3724

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamine B5 (Pantothenic Helps the skin hydration Non-compliance with the Regulation maintenance of normal 2010;8(10):1758 acid) and fights against because on the basis of the scientific skin exfoliation. evidence assessed, this claimed effect Helps to fight against for this food has not been skin dryness. substantiated. Art.13(1) Tryptophan Helps to a normal sleep Non-compliance with the Regulation Maintenance of normal 2011;9(4):2073 Helps to get a restful because on the basis of the scientific sleep sleep evidence assessed, this claimed effect Contributes to maintain for this food has not been nervous balance substantiated. Art.13(1) Prunus mume (Plum) Helps to balance the Non-compliance with the Regulation contribution to the 2011;9(6):2246 extract - INP-08 acidity of the body because on the basis of the scientific maintenance or Helps to promote the evidence assessed, this claimed effect achievement of a acide-base balance of for this food has not been normal body weight the body substantiated. Helps to the detoxification of the body Used to facilitate the weight loss Helps to loose weight Contributes to loose weight Used to facilitate the weight loss Helps in weight control Contributes to body weight management

Non-authorised

2878

Non-authorised

1671

Non-authorised

2325

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Rice vinegar extract - INRV Helps to balance the -08 acidity of the body Helps to promote the acide-base balance of the body Helps to the detoxification of the body Used to facilitate the weight loss Helps to loose weight Contributes to loose weight Used to facilitate the weight loss Helps in weight control Contributes to body weight management Art.13(1) 5-Hydroxytryptophan Helps to concentrate May reduce restlessness

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2246

Non-authorised

2333

Non-compliance with the Regulation attention because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1273

Non-authorised

1828

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat (Triticum vulgare)

Art.13(1) Wheat (Triticum vulgare)

Helps to control blood Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 levels of cholesterol. because on the basis of the scientific blood cholesterol Contributes to a healthy evidence assessed, this claimed effect concentrations cholesterol level and for this food has not been healthy blood vessels. substantiated. Contributes to a normal blood pressure. Helps to maintain a healthy heart. Contributes to normal cholesterol levels. Helps to reduce blood cholesterol levels. Helps to control blood Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 levels of cholesterol. because on the basis of the scientific blood pressure Contributes to a healthy evidence assessed, this claimed effect cholesterol level and for this food has not been healthy blood vessels. substantiated. Contributes to a normal blood pressure. Helps to maintain a healthy heart. Contributes to normal cholesterol levels. Helps to reduce blood cholesterol levels.

Non-authorised

599

Non-authorised

599

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Docosahexaenoic acid (DHA)

Helps to control body weight when combined with a healthy diet and exercise. Fits in a weight maintainance programme. Contributes to the reduction of body fat. Helps to control fat metabolism.

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2010;8(10):1734

Non-authorised

629

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Conjugated linoleic acid (CLA) ((cis-9, trans-11 conjugated linoleic acid, and trans-10, cis-12 conjugated linoleic acid (50:50) triglycerides)

Helps to control fat Non-compliance with the Regulation contribution to the metabolism because on the basis of the scientific maintenance or Influences lipid evidence assessed, this claimed effect achievement of a metabolism and storage for this food has not been normal body weight Increases lean muscle substantiated. mass Reduces body fat percentage Helps to reduce body fat mass while increasing lean body mass Helps to reduce body fat mass Helps to reduce the amount of fat you store after eating Helps to decrease the amount of fat stored in your body Helps to reduce you abdominal fat mass Helps to reduce fat mass in your abdomen and thighs Helps to improve your body shape Helps to increase lean body mass Helps reduce weight gain-helps to reduce SAD (sagittal abdominal

2010;8(10):1794

Non-authorised

1518

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

diameter)-helps to prevent the yoyo-effect after a diet Helps to reduce muscle protein loss during a diet Helps to increase feelings of fullness and satiety Art.13(1) SunfiberTM (syn.: Helps to control the rise Non-compliance with the Regulation Reduction of post2010;8(2):1465 BenefiberTM)(enzymaticall in blood glucose levels because on the basis of the scientific prandial glycaemic y partially depolymerised after a meal. Helps to evidence assessed, this claimed effect response guar gum) manage blood glucose for this food has not been levels after a meal. substantiated. Helps to balance blood glucose levels. Art.13(1) Policosanols Helps to decrease Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 cholesterol because on the basis of the scientific blood HDL-cholesterol biosynthesis, which is evidence assessed, this claimed effect concentrations higher during the night./ for this food has not been Helps to decrease substantiated. hepatic production of cholesterol, more elevated at night. Helps to control blood levels of cholesterol./ Helps to improve cholesterol profile.

Non-authorised

2932

Non-authorised

1954

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Policosanols

Art.13(1) Policosanols

Helps to decrease Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 cholesterol because on the basis of the scientific blood LDL-cholesterol biosynthesis, which is evidence assessed, this claimed effect concentrations higher during the night./ for this food has not been Helps to decrease substantiated. hepatic production of cholesterol, more elevated at night. Helps to control blood levels of cholesterol./ Helps to improve cholesterol profile. Helps to decrease Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 cholesterol because on the basis of the scientific blood HDL-cholesterol biosynthesis, which is evidence assessed, this claimed effect concentrations higher during the night./ for this food has not been Helps to decrease substantiated. hepatic production of cholesterol, more elevated at night./ Helps to control blood levels of cholesterol./ Helps to improve cholesterol profile.

Non-authorised

1954

Non-authorised

1951

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Policosanols

Art.13(1) Carnitine

Art.13(1) Formulated palm and oat oil emulsion

Helps to decrease Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 cholesterol because on the basis of the scientific blood LDL-cholesterol biosynthesis, which is evidence assessed, this claimed effect concentrations higher during the night./ for this food has not been Helps to decrease substantiated. hepatic production of cholesterol, more elevated at night./ Helps to control blood levels of cholesterol./ Helps to improve cholesterol profile. Helps to delay the onset Non-compliance with the Regulation increase in endurance 2011;9(6):2212 of fatigue. because on the basis of the scientific capacity Helps to maintain evidence assessed, this claimed effect energy levels for for this food has not been prolonged periods substantiated. during intense competition/exercise. Enhances endurance and helps to maintain peak effort during times of high physical demand. Helps to eat less. Non-compliance with the Regulation maintenance of body 2011;9(6):2252 Helps to reduce weight because on the basis of the scientific weight after weight loss regain after dieting. evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1951

Non-authorised

4305

Non-authorised

1553

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) digestive enzyme protease,Helps to encrease lipase, amylase, bioavailability of glucoamylase, invertase, nutritient from food, cellulase, malt diastase supports vitality and activity of organism, break down the foods we eat into basic building blocks that our body then absorbs and reassembles to build cells, tissues, organs, glands, and body systems and to reuse for more metabolic process

Non-compliance with the Regulation Improvement of the 2011;9(6):2228 because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation.

Non-authorised

3137

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Rubus idaeas (Raspberry) Helps to enhance the extract - BERI-08 thermogenesis production, wich in turn helps weight control Helps to control the appetit Naturally supports feeling of fullness after a meal Helps to manage appetit and hunger Helps to loose weight Contributes to loose weight Used to facilitate the weight loss Helps in weight control Contributes to body weight management Art.13(1) Taurine Helps to enhance tonus and vitality. Helps to support body's vitality. Helps to make you feel more energetic. Helps to improve physical well-being.

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2246

Non-authorised

2336

Non-compliance with the Regulation delay in the onset of 2011;9(4):2035 because on the basis of the scientific physical fatigue during evidence assessed, this claimed effect exercise for this food has not been substantiated.

Non-authorised

1958

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L/arginine

Art.13(1) L/arginine

Art.13(1) Citrullus lunatus (Watermelon) extract ACTI-08

Helps to improve blood circulation on pelvic level. / Helps protein synthesis and cellular replication with important role in the spermatogenesis process. Helps to improve blood circulation on pelvic level. / Helps protein synthesis and cellular replication with important role in the spermatogenesis process. Helps to improve carbohydrate and fat metabolism of the body Used to facilitate the weight loss Helps to loose weight Contributes to loose weight Used to facilitate the weight loss Helps in weight control Contributes to body weight management.

Non-compliance with the Regulation Contribution to normal 2011;9(4):2051 because on the basis of the scientific spermatogenesis evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

4682

Non-compliance with the Regulation Maintenance of normal 2011;9(4):2051 because on the basis of the scientific erectile function evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

4682

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2246

Non-authorised

2243

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic strain: Lactobacillus acidophilus LA-5

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. MSM Helps to improve Non-compliance with the Regulation contribution to normal methylsulfonylmetan regeneration and because on the basis of the scientific collagen formation nutrition of cartilage evidence assessed, this claimed effect for this food has not been substantiated. phenylalanin Helps to increase Non-compliance with the Regulation enhancement of mood activity of endorfins because on the basis of the scientific which induce sense of evidence assessed, this claimed effect joy, and has positive for this food has not been effect in pain substantiated. phenylalanin Helps to increase Non-compliance with the Regulation pain relief activity of endorfins because on the basis of the scientific which induce sense of evidence assessed, this claimed effect joy, and has positive for this food has not been effect in pain substantiated. Probiotic strain: Helps to increase Non-compliance with the Regulation not validated Bifidobacterium lactis W52 general wellbeing (when because on the basis of the scientific (Formerly known as constipated) evidence assessed, this food is not Bifidobacterium infantis sufficiently characterised for a W52) scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Helps to improve natural bowel movements

2010;8(2):1470

Non-authorised

3000

2010;8(10):1746

Non-authorised

388

2010;8(10):1748

Non-authorised

657

2010;8(10):1748

Non-authorised

657

2010;8(2):1470

Non-authorised

2990

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cranberry extract powder Helps to increase (Vaccinium macrocarpon) growth of beneficial microflora.

Non-compliance with the Regulation Defence against because on the basis of the scientific bacterial pathogens in evidence assessed, the evidence the lower urinary tract provided is insufficient to substantiate this claimed effect for this food. Art.13(1) Probiotic strain: Helps to increase sIgA Non-compliance with the Regulation not validated Bifidobacterium lactis W51 levels because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Medium Chain Helps to increase Non-compliance with the Regulation reduction in body Triglycerides (MCT) satiety after a meal because on the basis of the scientific weight /helps to increase evidence assessed, this claimed effect energy expenditure by for this food has not been increasing the metabolic substantiated. rate /helps with weight loss by increasing metabolic rate /tends to reduce body weight and fat in overweight persons Art.13(1) Isomalto-oligosaccharides Helps to keep blood Non-compliance with the Regulation reduction of postsugar levels low after because on the basis of the scientific prandial glycaemic each meal as part of a evidence assessed, this claimed effect responses healthy lifestyle. for this food has not been substantiated.

2011;9(6):2215

Non-authorised

3328

2010;8(2):1470

Non-authorised

3003

2011;9(6):2240

Non-authorised

1614

2010;8(10):1801

Non-authorised

798

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) lecithin phosphatidyl choline

Helps to keep normal cholesterol level

Art.13(1) Soy Isoflavones

Art.13(1) Lactotripeptides

Art.13(1) C12-peption

Helps to maintain a calm and comfortable menopause /helps women coping with the telltale signs associated with menopause, such as hot flushes, sweating, restlessness and irritability Helps to maintain a healthy blood pressure/contributes to a healthy blood pressure/helps to keep/control blood pressure at healthy levels/Helps to control blood pressure Helps to maintain a healthy blood pressure; Supports a healthy blood pressure.

Non-compliance with the Regulation maintenance of normal 2010;8(10):1741 because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Non-compliance with the Regulation Reduction of vasomotor 2011;9(7):2264, because on the basis of the scientific symptoms associated 2012;10(8):2847 evidence assessed, the evidence with menopause provided is insufficient to substantiate this claimed effect for this food.

Non-authorised

3138

Non-authorised 1654 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Maintenance of normal 2009;7(9):1259, because on the basis of the scientific blood pressure 2012;10(6):2715 evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised 2891 (expiry of transitional period 02/01/2014)

Non-compliance with the Regulation Maintenance of normal 2010;8(2):1478 because on the basis of the scientific blood pressure evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1483, 3130

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Methionine

Art.13(1) Lycopene

Art.13(1) PROPOLIS

Art.13(1) Pomegranate

Helps to maintain a Non-compliance with the Regulation maintenance of normal healthy cholesterol level because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Helps to maintain a Non-compliance with the Regulation contribution to normal healthy because on the basis of the scientific cardiac function heart/contributes to evidence assessed, this claimed effect maintain a healthy for this food has not been cardiovascular substantiated. system/contributes to protect the arteries from narrowing and hardening/contributes to keep the arteries healthy/helps to maintain a normal blood flow. Helps to maintain a Non-compliance with the Regulation not validated healthy liver function, because on the basis of the scientific supporting the digestion evidence assessed, this food is not and the body sufficiently characterised for a purification scientific assessment of this claimed effect and the claim could not therefore be substantiated. Helps to maintain a Non-compliance with the Regulation maintenance of normal healthy prostate. because on the basis of the scientific erectile function Contributes to healthy evidence assessed, this claimed effect sexual function in men. for this food has not been substantiated.

2010;8(10):1744

Non-authorised

706, 1615

2011;9(4):2031

Non-authorised

1610

2010;8(10):1810

Non-authorised

3527

2010;8(10):1750

Non-authorised

1163

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Momordica charantia (Common Name : balsam pear, bitter melon, bitter gourd, ampalaya, karela (karola), fu kwa) Art.13(1) Phosphatidyl choline / lecithin

Helps to maintain a normal blood glucose

Art.13(1) Phosphatidyl choline / lecithin

Art.13(1) Lactobacillus crispatus VPC111 (DSM 16741)

Art.13(1) Lactobacillus crispatus VPC177 (DSM 16743)

Non-compliance with the Regulation Maintenance of normal because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated. Helps to maintain a Non-compliance with the Regulation maintenance of normal normal cholesterol level. because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Helps to maintain a Non-compliance with the Regulation maintenance of normal normal cholesterol level; because on the basis of the scientific blood cholesterol Helps to maintain a evidence assessed, this claimed effect concentrations healthy heart. for this food has not been substantiated. Helps to maintain a Non-compliance with the Regulation not validated normal vaginal flora because on the basis of the scientific Supports a healthy evidence assessed, this food is not intestinal flora sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Helps to maintain a Non-compliance with the Regulation not validated normal vaginal flora because on the basis of the scientific Supports a healthy evidence assessed, this food is not intestinal flora sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1490

Non-authorised

2091

2010;8(10):1741

Non-authorised

1630

2010;8(10):1741

Non-authorised

709

2009;7(9):1247

Non-authorised

1079

2009;7(9):1247

Non-authorised

1080

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum HEAL 99 (DSM 15316 = 61A)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation not validated 2009;7(9):1247 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Magnesium hydroxide Helps to maintain acid- Non-compliance with the Regulation Reduction of gastric 2010;8(10):1807 base balance. because on the basis of the scientific acid levels Helps to decrease evidence assessed, this claimed effect dietary acid load. for this food is not a beneficial Helps in case of physiological effect as required by the occasional gastric Regulation. acidity. Contributes to decrease gastric acidity. Rutoside Helps to maintain Non-compliance with the Regulation improvement of 2010;8(10):1751 capillary integrity. because on the basis of the scientific endothelium-dependent evidence assessed, this claimed effect vasodilation for this food has not been substantiated. Tomato extract containing Helps to maintain Non-compliance with the Regulation protection of the skin 2011;9(4):2031 lycopene healthy appearance and because on the basis of the scientific from UV-induced structure of the skin evidence assessed, this claimed effect (including photowhen exposed to sun. for this food has not been oxidative) damage Helps protect the skin substantiated. from exposure to sun. Carnitine Helps to maintain Non-compliance with the Regulation maintenance of normal 2011;9(6):2212 healthy blood because on the basis of the scientific blood LDL-cholesterol cholesterol and plasma evidence assessed, this claimed effect concentrations lipid levels in the for this food has not been elderly. substantiated.

Helps to maintain a normal vaginal flora Supports a healthy intestinal flora

Non-authorised

1073

Non-authorised

376

Non-authorised

1649

Non-authorised

1665

Non-authorised

1494

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Rye fibre

Art.13(1) Bioflavonoids

Helps to maintain healthy cholesterol level. Brand name which contains the claim: Sydnystv "Friend of the heart". Clarification provided Helps to maintain healthy cholesterol level. Brand name which contains the claim: Sydnystv "Friend of the heart". Helps to maintain healthy venous circulation

Non-compliance with the Regulation maintenance of normal 2011;9(6):2258 because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

827

Art.13(1) Bioflavonoids from citrus

Helps to maintain healthy venous circulation.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2082

Non-authorised

1470

2011;9(4):2082

Non-authorised

1471

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Tomato extract containing Helps to maintain intact Non-compliance with the Regulation protection of DNA, lycopene cells. because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Art.13(1) Phenylalanine Helps to maintain Non-compliance with the Regulation increased alertness mental health and because on the basis of the scientific stimulates mental evidence assessed, this claimed effect alertness for this food has not been substantiated. Art.13(1) Xanthan Helps to maintain Non-compliance with the Regulation changes in bowel normal bowel function. because on the basis of the scientific function Promotes intestinal evidence assessed, this claimed effect regularity. for this food has not been Ensures a healthy substantiated. digestive system/ function. Art.13(1) Konjac mannan Helps to maintain Non-compliance with the Regulation maintenance of normal (glucomannan) normal bowel/colonic because on the basis of the scientific bowel function function. Helps to evidence assessed, this claimed effect promote intestinal for this food has not been regularity. Helps to substantiated. ensure healthy digestive functions. Helps to support gastrointestinal health. Helps to support intestinal function. Art.13(1) Tomato extract containing Helps to maintain Non-compliance with the Regulation protection of DNA, lycopene normal prostate health. because on the basis of the scientific proteins and lipids from Helps to maintain a evidence assessed, this claimed effect oxidative damage healthy prostate. for this food has not been substantiated.

2011;9(4):2031

Non-authorised

1663

2010;8(10):1748

Non-authorised

708

2011;9(6):2272

Non-authorised

837

2010;8(10):1798

Non-authorised

834

2011;9(4):2031

Non-authorised

1664

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Gamma-linolenic acid + eicosapentaenoic acid (GLA+EPA)

Art.13(1) Probiotic strain: Lactobacillus casei W56

Art.13(1) Probiotic strain: Lactococcus lactis W58

Helps to maintain strong Non-compliance with the Regulation maintenance of normal 2011;9(6):2224 bones because on the basis of the scientific bone contributes to the evidence assessed, this claimed effect maintenance of normal for this food has not been bone strength in post- substantiated. menopausal women contributes to the maintenance of normal bone strength in the elderly GLA with EPA help to preserve bone density Helps to maintain the Non-compliance with the Regulation not validated 2010;8(2):1470 balance of the intestinal because on the basis of the scientific microbiota by evidence assessed, this food is not suppressing nonsufficiently characterised for a beneficial bacteria scientific assessment of this claimed effect and the claim could not therefore be substantiated. Helps to maintain the Non-compliance with the Regulation not validated 2010;8(2):1470 balance of the intestinal because on the basis of the scientific microbiota by evidence assessed, this food is not suppressing nonsufficiently characterised for a beneficial bacteria scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

642

Non-authorised

2981

Non-authorised

2984

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic supplement: Lactobact omni FOS

Non-compliance with the Regulation not validated 2010;8(2):1470 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Vaccinium macrocarpon, Helps to maintain the Non-compliance with the Regulation Defence against 2011;9(6):2215 oxycoccus (Common Namehealth of the urinary because on the basis of the scientific bacterial pathogens in : Cranberry) system / contributes to evidence assessed, the evidence the lower urinary tract urinary tract health / has provided is insufficient to substantiate a beneficial effect on this claimed effect for this food. the urinary system / canneberge or Vaccinium macrocarpon by concentrated juices, by food supplements and a juice cocktail/nectar). Art.13(1) Food supplement /Food Helps to maintain the Non-compliance with the Regulation Defence against 2011;9(6):2215 ingredient : Whole health of the urinary because on the basis of the scientific bacterial pathogens in cranberry powder from system. evidence assessed, the evidence the lower urinary tract North American Cranberry Contributes to urinary provided is insufficient to substantiate (Vaccinium macrocarpon) tract health. this claimed effect for this food. Early Black species. Has a beneficial effect on the urinary system. Helps to eliminate pathogenic bacteria from urinary tract.

Helps to maintain the balance of the intestinal microbiota by suppressing nonbeneficial bacteria

Non-authorised

2997

Non-authorised

2153

Non-authorised

2770

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Galacto-oligosaccharides Helps to manage the symptoms associated with irritable bowel syndrome Art.13(1) 5-Hydroxytryptophan

Art.13(1) PROPOLIS

Non-compliance with the Regulation Reduction of gastro2011;9(4):2060 because on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated. Helps to promote Non-compliance with the Regulation enhancement of mood 2009;7(9):1273 healthy serotonin levels because on the basis of the scientific which can enhance evidence assessed, this claimed effect mood 5-HTP is the for this food has not been direct chemical substantiated. precursor to the neurotransmitter serotonin, which may promote a positive mood Helps to protect cells Non-compliance with the Regulation not validated 2010;8(10):1810 from oxidation. because on the basis of the scientific Helps maintain a evidence assessed, this food is not healthy immune system. sufficiently characterised for a Supports cell health & scientific assessment of this claimed function. effect and the claim could not therefore Well known source of be substantiated. antioxidants. Natural defense against free radicals. Soothing effect on throat and mouth.

Non-authorised

763

Non-authorised

1575

Non-authorised

1644

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Brassica olaracea var italica (broccoli)

Helps to protect cells Non-compliance with the Regulation not validated from oxidation. because on the basis of the scientific Supports cell health & evidence assessed, this food is not function. sufficiently characterised for a Well known source of scientific assessment of this claimed antioxidants. effect and the claim could not therefore Natural defense against be substantiated. free radicals. Helps the body to safely neutralize & excrete free radicals. Art.13(1) Extract from the red grapes Helps to protect cells Non-compliance with the Regulation Protection of DNA, skin from the free-radical because on the basis of the scientific proteins and lipids from damage Helps to evidence assessed, this claimed effect oxidative damage protect cells from the for this food has not been damage caused by free- substantiated. radical Art.13(1) Broccoli Sprout Powder Helps to protect the Non-compliance with the Regulation not validated bodies cells against because on the basis of the scientific oxidative stress evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Standardized tomato Helps to protect the skin Non-compliance with the Regulation protection of the skin extract [Oleoresin extractedfrom UV-induced because on the basis of the scientific from UV-induced from ripe fruits of oxidative damage, evidence assessed, this claimed effect (including photoLicopersicum aesculentum, Helps to protect against for this food has not been oxidative) damage solvent of extraction Ethyl UV-induced erythema, substantiated. acetate, 5% lycopene Helps to reduce skin reddening when exposed to sun

2011;9(6):2243

Non-authorised

2845

2010;8(2):1489

Non-authorised

2653

2011;9(6):2243

Non-authorised

1481

2011;9(4):2031

Non-authorised

2143

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carotenoids (alpha, beta and gamma carotene, lycopene)

Helps to protect the skin Non-compliance with the Regulation not validated 2011;9(4):2082 from the effects of UV because on the basis of the scientific radiation. evidence assessed, this food is not Reduces the skins sufficiently characterised for a susceptibility to burning. scientific assessment of this claimed Increases the skins sun effect and the claim could not therefore tolerance. be substantiated. Art.13(1) Melatonin Helps to reduce jet lag Non-compliance with the Regulation Reduction of sleep 2010;8(2):1467 effects Helps to reduce because on the basis of the scientific onset latency, and sleep onset latency evidence assessed, this claimed effect improvement of sleep Helps to regulate for this food has not been quality circadian rhythm substantiated. Improves sleep-wake cycle Contributes to improve sleep quality Helps to fall asleep in a natural way Art.13(1) Papaya (Carica papaya L.) Helps to reduce Non-compliance with the Regulation Prevention or treatment 2011;9(6):2228 localized excess fat. - because on the basis of the scientific of cellulitis Helps to limit cellulitis evidence assessed, this claimed effect thanks to its proteolytic attributes to this food the property of effect preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. Art.13(1) Pineapple (Ananas Helps to reduce Non-compliance with the Regulation Prevention or treatment 2011;9(6):2228 comosus L.) localized excess fat. - because on the basis of the scientific of cellulitis Helps to limit cellulitis evidence assessed, this claimed effect thanks to its proteolytic attributes to this food the property of effect preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods.

Non-authorised

1796

Non-authorised

1953

Non-authorised

2743

Non-authorised

3687

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Conjugated linoleic acid (CLA)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Helps to reduce muscle Non-compliance with the Regulation contribution to the 2010;8(10):1794 protein 'loss during a because on the basis of the scientific maintenance or diet evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated. Food supplement with 5- Helps to reduce the Non-compliance with the Regulation increase in satiety 2011;9(6):2198 hydroxytryptophane (5caloric intake because on the basis of the scientific leading to a reduction in HTP) Assists controlling evidence assessed, this claimed effect energy intake portions and snacking for this food has not been Promotes the syntheses substantiated. of serotonin, a known satiety factor EPA and DHA fatty acids Helps to regulate the Non-compliance with the Regulation maintenance of normal 2010;8(10):1796 blood sugar leve because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated. Amorphophallus konjac Helps to regulate transit Non-compliance with the Regulation maintenance of normal 2010;8(10):1798 KOCH (Common Name : time Helps to maintain a because on the basis of the scientific bowel function Konjac) good transit evidence assessed, this claimed effect for this food has not been substantiated. Lactobacillus rhamnosus Helps to restore and Non-compliance with the Regulation defence against vaginal 2011;9(6):2232 GR 1 (ATCC 55826) and maintain a normal because on the basis of the scientific pathogens by Lactobacilus reuteri RC 14 vaginal microflora evidence assessed, this claimed effect increasing the (ATCC 55845) for this food has not been proportion of lactobacilli substantiated. and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts

Non-authorised

726

Non-authorised

4223

Non-authorised

566

Non-authorised

3901

Non-authorised

945

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus LA14

Helps to restore and Non-compliance with the Regulation Defence against 2011;9(6):2248 maintain normal vaginal because on the basis of the scientific vaginal pathogens by microflora; evidence assessed, this claimed effect increasing the Helps during the for this food has not been proportion of lactobacilli treatment of urogenital substantiated. and/or decreasing the disorders; proportion of potentially pathogenic bacteria and/or yeasts Art.13(1) Lactobacillus acidophilus Helps to restore and Non-compliance with the Regulation not validated 2009;7(9):1247 rhamnosus LR(3) maintain normal vaginal because on the basis of the scientific microflora; evidence assessed, this food is not Helps during the sufficiently characterised for a treatment of urogenital scientific assessment of this claimed disorders; effect and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Helps to restore the Non-compliance with the Regulation not validated 2010;8(2):1470 Bifidobacterium lactis BI-07 intestinal microbiota because on the basis of the scientific (Formerly known as during and after evidence assessed, this food is not Bifidobacterium infantis BI- antibiotic use sufficiently characterised for a 07) scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Helps to restore the Non-compliance with the Regulation not validated 2010;8(2):1470 Bifidobacterium lactis Bl-04 intestinal microbiota because on the basis of the scientific (Formerly known as during and after evidence assessed, this food is not Bifidobacterium lactis BL- antibiotic use sufficiently characterised for a 01 and Bifidobacterium scientific assessment of this claimed longum BI-04) effect and the claim could not therefore be substantiated.

Non-authorised

946

Non-authorised

947

Non-authorised

2992

Non-authorised

2994

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic strain: Lactobacillus acidophilus LA-5

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Helps to restore the Non-compliance with the Regulation not validated Lactobacillus salivarius LS- intestinal microbiota because on the basis of the scientific 33 during and after evidence assessed, this food is not antibiotic use sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Beta-Carotene Helps to retard skin Non-compliance with the Regulation protection of the skin aging. because on the basis of the scientific from UV-induced Contributes to maintain evidence assessed, this claimed effect (including photoa healthy skin. for this food has not been oxidative) damage Promotes healthy skin substantiated. pigmentation and tanning. The anti-oxidant properties of Beta carotene help maintain a healthy and elastic skin. Contributes to the maintenance of healthy skin

Helps to restore the intestinal microbiota during and after antibiotic use

2010;8(2):1470

Non-authorised

3001

2009;7(9):1247

Non-authorised

2991

2011;9(4):2021

Non-authorised

1461

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus LB21 NCIMB 40564 (Verum Hlsoyoghurt/ Verum Drickyoghurt)

Helps to strengthen and Non-compliance with the Regulation contribution to maintain balance in the because on the basis of the scientific maintaining individual gut flora evidence assessed, this claimed effect intestinal microbiota in for this food has not been subjects receiving substantiated. antibiotic treatment Art.13(1) Lactococcus lactis L1A Helps to strengthen and Non-compliance with the Regulation not validated NCIMB 40157 maintain balance in the because on the basis of the scientific (Verum Hlsofil) gut flora evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus johnsonii BFEHelps to strengthen Non-compliance with the Regulation natural 6128 natural defences because on the basis of the scientific defences/immune Stimulates immune evidence assessed, this claimed effect system system for this food is not sufficiently defined Strengthens resistance to be able to be assessed and the of organism claim could not therefore be substantiated. Art.13(1) Lactobacillus plantarum Helps to strengthen Non-compliance with the Regulation natural BFE 1685 natural defences because on the basis of the scientific defences/immune Stimulates immune evidence assessed, this claimed effect system system for this food is not sufficiently defined Strengthens resistance to be able to be assessed and the of organism claim could not therefore be substantiated.

2011;9(4):2029

Non-authorised

1061

2009;7(9):1247

Non-authorised

1060

2011;9(4):2026

Non-authorised

990

2011;9(4):2028

Non-authorised

993

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cordyceps sinensis

Helps to strengthen the body Supports immune system Invigorates the body Supports energetic alertness Supports the immunesystem by delivering antioxidants Increases performance and endurance of a heavy exercise or sportsactivity Art.13(1) Probiotic strain: Helps to strengthen the Bifidobacterium lactis W52 intestinal gut barrier (Formerly known as Bifidobacterium infantis W52)

Non-compliance with the Regulation increase in endurance 2011;9(6):2247 because on the basis of the scientific performance evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

3127

Art.13(1) Probiotic strain: Lactobacillus casei W58

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Helps to strengthen the Non-compliance with the Regulation not validated intestinal gut barrier because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

2988

2010;8(2):1470

Non-authorised

2982

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic strain: Lactobacillus salivarius W24

Helps to strengthen the Non-compliance with the Regulation not validated intestinal gut barrier because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Probiotic strain: Helps to strengthen the Non-compliance with the Regulation not validated Lactococcus lactis W61 intestinal gut barrier because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) milk phospholipids Helps to strengthen the Non-compliance with the Regulation immune milk fat globule membrane natural defences. Helps because on the basis of the scientific function/immune to support the natural evidence assessed, this claimed effect system defences. Helps to for this food is not sufficiently defined support the body's to be able to be assessed and the defences. Helps to claim could not therefore be strengthen the body's substantiated. defences. les phospholipides laitiers participent aux dfenses naturelles

2010;8(2):1470

Non-authorised

2979

2010;8(2):1470

Non-authorised

2985

2010;8(10):1799

Non-authorised

605

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Nutrient, substance, food or food category

Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Green Clay

Helps to support digestion. Contributes to digestive comfort. Contributes to normal function of the gastrointestinal tract. Helps to reduce gastrointestinal discomfort. Helps to improve the digestive transit. Helps to regulate digestion. Contributes to digestive well-being Art.13(1) Grape (Vitis vinifera L) Helps to support in weight loss programs. Helps to support slimming. Helps silhouette to become more refined. Useful in weight loss management. Art.13(1) Flax (Linum usitatissimum) Helps to support mood. Contributes to emotionnal well-being. Helps to support relaxation and mental well-being. Contributes to optimal relaxation.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

1952

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2246

Non-authorised

2727

Non-compliance with the Regulation Enhancement of mood 2011;9(4):2050 because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

3182

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Flax (Linum usitatissimum) Helps to support mood. Contributes to emotionnal well-being. Helps to support relaxation and mental well-being. Contributes to optimal relaxation. Clarification provided Thanks to its high essential fatty acids content, flax enhances mood. Flax increases relaxation. Art.13(1) Citrus limon (Common Helps to support the Name : Lemon) digestion contributes to the normal function of intestinal tract helps support the digestive juice flow. Art.13(1) Wheat grain fibre Helps with weight control

Non-compliance with the Regulation Enhancement of mood 2011;9(4):2050 because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

601

Non-compliance with the Regulation reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2248

Non-authorised

2028

2010;8(10):1817

Non-authorised

829

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wholegrain

Art.13(1) Barley grain fibre

Art.13(1) Oat grain fibre

Helps with weight Non-compliance with the Regulation not validated control. because on the basis of the scientific For a long-lasting sense evidence assessed, this food is not of satiety. sufficiently characterised for a Releases energy slowly scientific assessment of this claimed effect and the claim could not therefore be substantiated. Helps with weight Non-compliance with the Regulation maintenance or control. For long-lasting because on the basis of the scientific achievement of a sense of satiety. Frees evidence assessed, this claimed effect normal body weight energy slowly for this food has not been substantiated. Helps with weight Non-compliance with the Regulation maintenance or control. For long-lasting because on the basis of the scientific achievement of a sense of satiety. Frees evidence assessed, this claimed effect normal body weight energy slowly for this food has not been substantiated.

2010;8(10):1766

Non-authorised

832

2009;7(9):1254

Non-authorised

820

2009;7(9):1254

Non-authorised

823

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Xanthan

Helps you to feel full for longer. Helps to limit feeling of hunger and food craving. Helps to increase feelings of fullness and satiety. Curbs the appetite. Helps in weight control programs by reducing appetite and calorie intake. Contributes to control/ reduce appetite. Helps to reduce body weight. Art.13(1) Carbohydrate, protein and Helps your body rapidly lipid combination rebuild so that you can perform at your peak during your next workout. Rebuild muscle glycogen. Repair muscle protein. Restore muscle lipid.

Non-compliance with the Regulation increased satiety because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(2):1481

Non-authorised

838

Non-compliance with the Regulation increase in endurance 2011;9(6):2247 because on the basis of the scientific performance during the evidence assessed, this claimed effect subsequent exercise for this food has not been bout after strenuous substantiated. exercise

Non-authorised

462

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) A combination of three probiotic ingredients; Lactobacillus casei F19, Bifidobacterium lactis Bb12, Lactobacillus acidophilus La5

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Peptides (milk products Helps/help to control Non-compliance with the Regulation Maintenance of normal fermented with L. blood pressure. because on the basis of the scientific blood pressure Helveticus lactic acid evidence assessed, this claimed effect bacteria) for this food has not been substantiated. Art.13(1) Homotaurine Homotaurine has been Non-compliance with the Regulation contribution to normal shown to help maintain because on the basis of the scientific cognitive function cognitive function. evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Natural mineral water: Hydrogencarbonates Non-compliance with the Regulation Reduction of gastric Hydrogencarbonates as Naneutralize stomach acid. because on the basis of the scientific acid - , Mg-, Ca-, salts: evidence assessed, this claimed effect NaHCO3, for this food is not a beneficial Mg(HCO3)2,Ca(HCO3)2 physiological effect as required by the Regulation.

Helps your natural bowel regularity Helps to regulate your intestinal flora

2009;7(9):1247

Non-authorised

1085

2009;7(9):1259, 2012;10(6):2715

Non-authorised 1831 (expiry of transitional period 02/01/2014) Non-authorised 1926

2011;9(6):2248

2011;9(6):2228

Non-authorised

2886

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Nuts

Il consumo regolare di Non-compliance with the Regulation not validated 20 grammi di noci ogni because on the basis of the scientific giorno aiuta a evidence assessed, this food is not combattere sufficiently characterised for a l'ipertensione scientific assessment of this claimed Clarification provided effect and the claim could not therefore Regular intake of 20 be substantiated. grams of nuts every day helps to preserve normal blood pressure Art.13(1) Probiotics (Lactobacillus Immunox Probiotic and Non-compliance with the Regulation not validated acidophilus, Antioxidant supports because on the basis of the scientific Bifidobacterium breve, digestive health and evidence assessed, this food is not <em>Bifidobacterium immunity. sufficiently characterised for a longum</em>, scientific assessment of this claimed Bifidobacterium infantis) & Immunox Probiotic effect and the claim could not therefore Antioxidants (Vitamin C, supports immunity and be substantiated. Green Tea Extract, Grape resistance to infection. Seed Extract, Pine Bark Extract) as contained in the Immunox Probiotic and probiotic formula Immunox Antioxidant strengthens the bodys natural defences Immunox is a probiotic and antioxidant Important for brain Non-compliance with the Regulation cognitive function functioning. Protects the because on the basis of the scientific brain. Regulates nerve evidence assessed, this claimed effect impulse progression for this food has not been substantiated.

2011;9(4):2032

Non-authorised

1305

2009;7(9):1247

Non-authorised

1096

Art.13(1) Manganese

2009;7(9):1217

Non-authorised

340

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Inositol

Art.13(1) Dimetilsolfone

Art.13(1) Dimetilsolfone

Important for the Non-compliance with the Regulation Nervous system 2011;9(6):2228 function of the nervous because on the basis of the scientific function system. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Importante sorgenti di Non-compliance with the Regulation contribution to normal 2010;8(10):1746 zolfo biodisponibile, because on the basis of the scientific collagen formation utile per una corretta evidence assessed, this claimed effect sintesi della cheratina,la for this food has not been principale proteina substantiated. costutuente le unghie. Clarification provided Source of bioavailable sulphur useful for the physiological synthesis of keratin the main constituent of nails Importante sorgenti di Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 zolfo biodisponibile, because on the basis of the scientific nails utile per una corretta evidence assessed, this claimed effect sintesi della cheratina,la for this food has not been principale proteina substantiated. costutuente le unghie. Clarification provided Source of bioavailable sulphur useful for the physiological synthesis of keratin the main constituent of nails

Non-authorised

1732

Non-authorised

1695

Non-authorised

1695

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cocoa (Theobroma cacao Improve emotional well- Non-compliance with the Regulation enhancement of mood 2011;9(6):2269 L.) being. Support positive because on the basis of the scientific mood. Increase evidence assessed, this claimed effect relaxation for this food has not been substantiated. Art.13(1) Phosphatidylcholine Improve the glutamine's Non-compliance with the Regulation increase in the 2010;8(10):1741 effect in sportsmen. because on the basis of the scientific intestinal absorption of Improve the intestinal evidence assessed, this claimed effect glutamine absorption of glutamine. for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Phosphatidylcholine Improve the Non-compliance with the Regulation improvement of 2010;8(10):1741 neuromuscular because on the basis of the scientific neuromuscular function functions evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Branched-chain amino Improvement of muscle Non-compliance with the Regulation growth or maintenance 2010;8(10):1790 acids (BCAA) recovery after exercise because on the basis of the scientific of muscle mass Improvement of muscle evidence assessed, this claimed effect L-leucine protein synthesis for this food has not been L-valine substantiated. L-isoleucine

Non-authorised

4276

Non-authorised

4251

Non-authorised

4250

Non-authorised

451

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Adenosine triphosphate (ATP)

Improves effectively Non-compliance with the Regulation maintenance of normal muscular tonus because on the basis of the scientific muscle function Helps muscle recovery / evidence assessed, this claimed effect supports muscle fatigue for this food has not been recovery substantiated. Supports dorsal comfort Contributes to the reduction of muscle soreness Contributes to the reduction of muscle contracture Contributes to the reduction of muscular tension Art.13(1) Water-based product Improves gallbladder Non-compliance with the Regulation Improves mechanical (Water purified by reverse mechanoactivity because on the basis of the scientific activity of gallbladder osmosis to monomolecular evidence assessed, this claimed effect level, complex of salts) for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Hydrolised guar gum Improves health Non-compliance with the Regulation changes in bowel bowel/helps promote because on the basis of the scientific function regularity evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Sunfiber (enzymatically Improves intestinal Non-compliance with the Regulation changes in bowel partially depolymerised comfort in people with because on the basis of the scientific function guar gum) irritable bowel syndrom evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2081

Non-authorised

1946

2011;9(6):2228

Non-authorised

1342

2011;9(6):2254

Non-authorised

853

2011;9(6):2254

Non-authorised

2930

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sunfiber (enzymatically partially depolymerised guar gum)

Art.13(1) Sunfiber(enzymatically partially depolymerised guar gum).

Art.13(1) Sunfiber(enzymatically partially depolymerised guar gum).

Art.13(1) Sunfiber(enzymatically partially depolymerised guar gum).

Art.13(1) Sunfiber(enzymatically partially depolymerised guar gum).

Art.13(1) Sunfiber(enzymatically partially depolymerised guar gum).

Improves intestinal Non-compliance with the Regulation reduction of gastrocomfort in people with because on the basis of the scientific intestinal discomfort irritable bowel syndrom evidence assessed, this claimed effect for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation changes in bowel comfort in people with because on the basis of the scientific function irritable bowel syndrom evidence assessed, this claimed effect for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation reduction of gastrocomfort in people with because on the basis of the scientific intestinal discomfort irritable bowel syndrom evidence assessed, this claimed effect for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation changes in bowel regularity. because on the basis of the scientific function Improves bowel function evidence assessed, this claimed effect and gut comfort. for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation reduction of gastroregularity. because on the basis of the scientific intestinal discomfort Improves bowel function evidence assessed, this claimed effect and gut comfort. for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation changes in bowel regularity. because on the basis of the scientific function Improves bowel function evidence assessed, this claimed effect and gut comfort. for this food has not been Promotes a normal substantiated. intestinal function.

2011;9(6):2254

Non-authorised

2930

2011;9(6):2254

Non-authorised

1903

2011;9(6):2254

Non-authorised

1903

2011;9(6):2254

Non-authorised

1902

2011;9(6):2254

Non-authorised

1902

2011;9(6):2254

Non-authorised

1904

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sunfiber(enzymatically partially depolymerised guar gum).

Art.13(1) Sunfiber (enzymatically partially depolymerised guar gum)

Art.13(1) Sunfiber (enzymatically partially depolymerised guar gum)

Art.13(1) Sunfiber (enzymatically partially depolymerised guar gum)

Art.13(1) Sunfiber (enzymatically partially depolymerised guar gum)

Improves intestinal Non-compliance with the Regulation reduction of gastroregularity. because on the basis of the scientific intestinal discomfort Improves bowel function evidence assessed, this claimed effect and gut comfort. for this food has not been Promotes a normal substantiated. intestinal function. Improves intestinal Non-compliance with the Regulation changes in bowel regularity; Improves because on the basis of the scientific function bowel function and gut evidence assessed, this claimed effect comfort for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation reduction of gastroregularity; Improves because on the basis of the scientific intestinal discomfort bowel function and gut evidence assessed, this claimed effect comfort for this food has not been substantiated. Improves intestinal Non-compliance with the Regulation changes in bowel regularity; Improves because on the basis of the scientific function bowel function and gut evidence assessed, this claimed effect comfort ; Promotes a for this food has not been normal intestinal substantiated. function Improves intestinal Non-compliance with the Regulation reduction of gastroregularity; Improves because on the basis of the scientific intestinal discomfort bowel function and gut evidence assessed, this claimed effect comfort ; Promotes a for this food has not been normal intestinal substantiated. function

2011;9(6):2254

Non-authorised

1904

2011;9(6):2254

Non-authorised

2929

2011;9(6):2254

Non-authorised

2929

2011;9(6):2254

Non-authorised

2931

2011;9(6):2254

Non-authorised

2931

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Creatine

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Improves mental Non-compliance with the Regulation Increased attention attentiveness because on the basis of the scientific Improved powers of evidence assessed, this claimed effect concentration and ability for this food has not been to absorb information substantiated. Assists in mental performance Creatine Improves mental Non-compliance with the Regulation Improvement of attentiveness also in the because on the basis of the scientific memory elderly evidence assessed, this claimed effect for this food has not been substantiated. Gamma linolenic acid Improves mobility and Non-compliance with the Regulation Maintenance of bone elasticity of joints. because on the basis of the scientific Activates absorption of evidence assessed, this claimed effect calcium in intestinal for this food has not been tract thus increasing substantiated. bone tissue density Gamma linolenic acid Improves mobility and Non-compliance with the Regulation Maintenance of joints elasticity of joints. because on the basis of the scientific Activates absorption of evidence assessed, this claimed effect calcium in intestinal for this food has not been tract thus increasing substantiated. bone tissue density Herbal yeast plasmolycate Improves performance Non-compliance with the Regulation not validated (saccharomyces because on the basis of the scientific cerevisiae) evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2216

Non-authorised

1524

2011;9(6):2216

Non-authorised

1528

2010;8(2):1477

Non-authorised

1774

2010;8(2):1477

Non-authorised

1774

2011;9(6):2243

Non-authorised

1815

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Page 531

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Caffeine (from tea/coffee/chocolate or added in pure form)

Improves physical performance.

Art.13(1) Brewer`s Yeast

Art.13(1) Brewer`s Yeast

Art.13(1) L-carnitine

Art.13(1) Probiotic strain: Lactobacillus acidophilus LA-5

Non-compliance with the Regulation Increase in physical because on the basis of the scientific performance during evidence assessed, this claimed effect short-term highfor this food has not been intensity exercise substantiated. Improves skin, hair and Non-compliance with the Regulation Maintenance of normal nail condition because on the basis of the scientific structure and evidence assessed, this claimed effect appearance of hair and has not been linked to a function of the nails body, as required by Article 13 of the Regulation. Improves skin, hair and Non-compliance with the Regulation Maintenance of nail condition because on the basis of the scientific structure and elasticity evidence assessed, this claimed effect of the skin has not been linked to a function of the body, as required by Article 13 of the Regulation. Improves sperm quality. Non-compliance with the Regulation contribution to normal because on the basis of the scientific spermatogenesis evidence assessed, this claimed effect for this food has not been substantiated. Improves the absorption Non-compliance with the Regulation not validated of lactose because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2053

Non-authorised

737, 1486

2011;9(6):2228

Non-authorised 1385 (expiry of transitional period 02/01/2014)

2011;9(6):2228

Non-authorised 1385 (expiry of transitional period 02/01/2014)

2011;9(6):2212

Non-authorised

1822

2010;8(2):1470

Non-authorised

2999

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sulfur amino acids : methionine and cystine

Art.13(1) Sulfur amino acids : methionine and cystine

Art.13(1) Phospolipids

Art.13(1) Fructose

Improves the conditions Non-compliance with the Regulation maintenance of normal of hair and nails. Helps because on the basis of the scientific hair to support the hairs evidence assessed, this claimed effect vitality. Improve hair for this food has not been growth . Helps hair to substantiated. be glossy. Strenghten hair and nails. Useful in case of fragile nails Improves the conditions Non-compliance with the Regulation maintenance of normal of hair and nails. Helps because on the basis of the scientific nails to support the hairs evidence assessed, this claimed effect vitality. Improve hair for this food has not been growth . Helps hair to substantiated. be glossy. Strenghten hair and nails. Useful in case of fragile nails Improves the memory. Non-compliance with the Regulation memory, learning Improves the memory, because on the basis of the scientific capacity and attention, and learning and evidence assessed, this claimed effect and function of the concentrative ability. for this food has not been nervous system Strengthens the substantiated. nervous system. Improves well-being Non-compliance with the Regulation "mental health" after alcohol use because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1795

Non-authorised

597

2010;8(10):1795

Non-authorised

597

2009;7(9):1246

Non-authorised

1835

2011;9(6):2228

Non-authorised

555

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coenzyme Q10;ubiquinoneIn case of increased Non-compliance with the Regulation contribution to normal 2010;8(10):1793 energy needs of the because on the basis of the scientific energy-yielding body or for increased evidence assessed, this claimed effect metabolism mental or physical for this food has not been performance or for substantiated. supporting the energy supply of the overloaded muscles, such as skeletal muscles, heart muscle. Art.13(1) Natural Grape Extract In healthy balanced diet Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 From red grape skin natural Grape because on the basis of the scientific proteins and lipids from antioxidants help to evidence assessed, this claimed effect oxidative damage protect body's cells for this food has not been against free-radicals, substantiated. and so make a contribution towards reinforcing body's defences With natural grape antioxidants With natural grape polyphenols

Non-authorised

1912

Non-authorised

2059

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Natural Grape Extract From white grape skin Solvent free

In healthy balanced diet Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 natural Grape because on the basis of the scientific proteins and lipids from antioxidants help to evidence assessed, this claimed effect oxidative damage protect body's cells for this food has not been against free-radicals, substantiated. and so make a contribution towards reinforcing body's defences With natural grape polyphenols With natural grape antioxidants Art.13(1) Palm/oat oil fatty acid In studies found to Non-compliance with the Regulation contribution to the 2011;9(6):2252 increase and prolong because on the basis of the scientific maintenance or the sense of satiety. evidence assessed, this claimed effect achievement of a Helps to control appetite for this food has not been normal body weight during the day. substantiated. Increases the feeling of satiety Art.13(1) Berries and fruit Includes (natural) Non-compliance with the Regulation not validated 2011;9(4):2082 juices/flavonoids + ascorbicflavonoids and other because on the basis of the scientific acid antioxidants. Berry/fruit evidence assessed, this food is not juice contains a number sufficiently characterised for a of constituents with an scientific assessment of this claimed antioxidative effect that effect and the claim could not therefore protect the body from be substantiated. damage caused by free radicals. Symbol included in the claim: MarliVital

Non-authorised

2061

Non-authorised

577

Non-authorised

1186

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Antioxidants

Art.13(1) Antioxidants

Art.13(1) Soya (Glycine max [L.] Merr.)

Art.13(1) Soluble Fibre (from oat, psyllium, pectin or guar gum)

Inclusion of antioxidants Non-compliance with the Regulation protection of DNA, in the diet may help because on the basis of the scientific proteins and lipids from maintain a healthy heart evidence assessed, this claimed effect oxidative damage Clarification provided for this food has not been Inclusion of antioxidants substantiated. in the diet may help maintain a healthy heart Inclusion of antioxidants Non-compliance with the Regulation protection of cells from in the diet may help because on the basis of the scientific premature aging protect the skin from the evidence assessed, this claimed effect effects of ageing for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Inclusion of at least 25g Non-compliance with the Regulation maintenance of normal [or 40-90 mg soy because on the basis of the scientific blood LDL-cholesterol isoflavones] soya evidence assessed, this claimed effect concentrations protein per day as part for this food has not been of a diet low in substantiated. saturated fat promotes heart health / helps control blood cholesterol. Inclusion of this fibre in Non-compliance with the Regulation not validated a healthy diet and because on the basis of the scientific lifestyle can lead to evidence assessed, this food is not serum cholesterol sufficiently characterised for a reduction. scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1752

Non-authorised

1440

2010;8(10):1752

Non-authorised

1917

2011;9(7):2264

Non-authorised

1135

2010;8(10):1735

Non-authorised

4330

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Page 536

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) DL-Methionine and LIncrease hair and nail Non-compliance with the Regulation maintenance of normal cystine sulphur amino acidsresistance and promote because on the basis of the scientific hair their growth evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) DL-Methionine and LIncrease hair and nail Non-compliance with the Regulation maintenance of normal cystine sulphur amino acidsresistance and promote because on the basis of the scientific nails their growth evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Sugar cane extract Increases beneficial Non-compliance with the Regulation maintenance of normal HDL cholesterol./ because on the basis of the scientific blood HDL-cholesterol Beneficial for the heart evidence assessed, this claimed effect concentrations and blood vessels. for this food has not been substantiated. Art.13(1) Sugar cane extract Increases beneficial Non-compliance with the Regulation maintenance of normal HDL cholesterol./ because on the basis of the scientific blood LDL-cholesterol Beneficial for the heart evidence assessed, this claimed effect concentrations and blood vessels. for this food has not been substantiated.

2010;8(10):1795

Non-authorised

4224

2010;8(10):1795

Non-authorised

4224

2011;9(6):2255

Non-authorised

1864

2011;9(6):2255

Non-authorised

1864

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Page 537

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Epigallocatechin gallate (ECGC) + caffeine

Increases burning of Non-compliance with the Regulation Contribution to the calories. because on the basis of the scientific maintenance or Stimulates your evidence assessed, this claimed effect achievement of a metabolism to burn for this food has not been normal body weight calories. substantiated. Stimulates your body to enhance the calorie burning process. Stimulates your metabolism. Three servings per day have been shown to increase calorie burning by approximately 106 calories. Symbol included in the claim: Brand included in the claim: ENVIGA CALORIE BURNER INVIGORATE YOUR METABOLISM Art.13(1) Chitosan-Natural insoluble Increases in volume in Non-compliance with the Regulation reduction of intestinal fibre from crustaceans shellthe interior of the because on the basis of the scientific transit time digestive tube by evidence assessed, this claimed effect hydration, launches for this food has not been laxation in non-irritative substantiated. way.

2011;9(4):2058

Non-authorised

1800

2011;9(6):2214

Non-authorised

4664

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Creatine

Art.13(1) Whey protein isolate (Lacprodan DI-9212)

Art.13(1) Wheat germ oil

Art.13(1) PROPOLIS

Art.13(1) Potato protein isolate

Increases muscle power Non-compliance with the Regulation increase in endurance 2011;9(7):2303 and speed', 'Provide because on the basis of the scientific performance energy to muscle evidence assessed, this claimed effect for this food has not been substantiated. Increases muscle Non-compliance with the Regulation growth or maintenance 2010;8(10):1818 synthesis because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated. Increases potency Non-compliance with the Regulation contribution to normal 2010;8(10):1762 because on the basis of the scientific fertility evidence assessed, this claimed effect for this food has not been substantiated. Increases the Non-compliance with the Regulation not validated 2010;8(10):1810 physiological resistance because on the basis of the scientific of the organism in case evidence assessed, this food is not of severe ambiance sufficiently characterised for a conditions scientific assessment of this claimed effect and the claim could not therefore be substantiated. Increases the sense of Non-compliance with the Regulation increase in satiety 2011;9(6):2246 satiety because on the basis of the scientific leading to a reduction in Elicit satiety evidence assessed, this claimed effect energy intake Reduces appetite for this food has not been Supports weight control substantiated.

Non-authorised

1963

Non-authorised

4307

Non-authorised

1392

Non-authorised

3798

Non-authorised

2894

Generated on: 28/01/2014 09:37 AM

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Increasing fiber intake Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 helps maintain digestive because on the basis of the scientific bowel function health. evidence assessed, this claimed effect Wheat dextrin promotes for this food has not been healthy functioning of substantiated. your digestive system. Wheat dextrin helps your natural bowel regularity. Wheat dextrin helps to restore normal digestive health. Wheat dextrin is a natur

Non-authorised

1680

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Increasing fiber intake Non-compliance with the Regulation decreasing potentially 2010;8(10):1761 helps maintain digestive because on the basis of the scientific pathogenic gastrohealth. evidence assessed, this claimed effect intestinal Wheat dextrin promotes for this food has not been microorganisms healthy functioning of substantiated. your digestive system. Wheat dextrin helps your natural bowel regularity. Wheat dextrin helps to restore normal digestive health. Wheat dextrin is a natural solution when it concerns your digestive health. Wheat dextrin helps to supplement your daily diet with fiber that is essential to keep your bowel healthy. Wheat dextrin helps restore your digestive systems natural balance.

Non-authorised

843

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Page 541

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Increasing fiber intake Non-compliance with the Regulation maintenance of normal 2010;8(10):1761 helps maintain digestive because on the basis of the scientific bowel function health. evidence assessed, this claimed effect Wheat dextrin promotes for this food has not been healthy functioning of substantiated. your digestive system. Wheat dextrin helps your natural bowel regularity. Wheat dextrin helps to restore normal digestive health. Wheat dextrin is a natural solution when it concerns your digestive health. Wheat dextrin helps to supplement your daily diet with fiber that is essential to keep your bowel healthy. Wheat dextrin helps restore your digestive systems natural balance.

Non-authorised

843

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Indole-3-carbinol

Art.13(1) Indole-3-carbinol

Art.13(1) Pectins

Indole-3-carbinol Non-compliance with the Regulation Hormonal balance 2011;9(6):2228 supports the defence because on the basis of the scientific ability of female evidence assessed, this claimed effect reproductive organs for this food is not sufficiently defined (ovaria, uterus, to be able to be assessed and the breasts). Indole-3claim could not therefore be carbinol helps to substantiated. support the healthy development and fission of soft tissues of male and female reproductive organs, stomach, colon and larynx. Indole-3-carbinol Non-compliance with the Regulation apoptosis of damaged 2011;9(6):2248 supports the regular because on the basis of the scientific cells fenotype of cells and evidence assessed, this claimed effect positively affects the for this food has not been induction of apoptosis of substantiated. damaged cells Induce satiety sensation Non-compliance with the Regulation increase in satiety 2010;8(10):1747 because on the basis of the scientific leading to a reduction in evidence assessed, this claimed effect energy intake for this food has not been substantiated.

Non-authorised

2916

Non-authorised

2917

Non-authorised

4692

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Konjac mannan (glucomannan)

Art.13(1) L/arginine

Induces a low glycemic Non-compliance with the Regulation maintenance of normal 2010;8(10):1798 response. Helps to because on the basis of the scientific blood glucose control/ balance blood evidence assessed, this claimed effect concentrations glucose/insulin level. for this food has not been Sustain steady blood substantiated. sugar levels. Helps to maintain and improve blood glucose control. Helps in the management of regular blood glucose level. Helps to maintain insulin sensitivity. Helps to support glycemic control. Interferes in the Non-compliance with the Regulation Maintenance of normal 2011;9(4):2051 ureogenesis, helping because on the basis of the scientific ammonia clearance the elimination of evidence assessed, no conditions of ammonia. use to accompany this claim could be defined.

Non-authorised

835

Non-authorised 4683 (expiry of transitional period 02/01/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bioflavonoids

Art.13(1) Inulin/oligofructose

Interviene positivamente sul trofismo microcircolatorio - per favorire i processi di protezione dei piccoli vasi venosi. concorre alla protezione dallazione nociva dei radicali liberi sullorganismo e da quella dei raggi ultravioletti sulla pelle. Clarification provided Antioxidant effects to enhance the microcirculation resistance and protection of venous vessels fron the attack of free radicals. Inulin/oligofructose enhances calcium absorption

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2082

Non-authorised

1693

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2244

Non-authorised

849

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Inulin/oligofructose from chicory

Art.13(1) Omega-3 fish body oil PUFAs

Art.13(1) Iron

Inulin/oligofructose help you to feel fuller for longer; Foods with inulin/oligofructose curb your hunger feeling; Foods with inulin/oligofructose make you feel satisfied Involved in the immune system May help maintain a healthy immune system May help maintain healthy joints Joint care Iron affects activity of heart, liver and muscles.

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation maintenance of joints because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2244

Non-authorised

2922

2009;7(9):1263

Non-authorised

524

Art.13(1) Iron

Non-compliance with the Regulation activity of heart, liver 2010;8(10):1740 because on the basis of the scientific and muscles evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Iron is needed to allow Non-compliance with the Regulation biotransformation of 2010;8(10):1740 the body metabolise because on the basis of the scientific xenobiotic substances drugs and other evidence assessed, this claimed effect substances. Iron for this food is not sufficiently defined contributes to the to be able to be assessed and the bodys ability to claim could not therefore be metabolise drugs and substantiated. other substances. Iron is needed for the metabolism of drugs.

Non-authorised

397

Non-authorised

258

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Alpha-lipoic-acid

Art.13(1) Beta-Carotene

Art.13(1) Lactium milk protein hydrolysate

Is an antioxidant Acts Non-compliance with the Regulation Protection of body lipids 2010;8(2):1474 as an antioxidant Helps because on the basis of the scientific from oxidative damage to reduce oxidative evidence assessed, this claimed effect stress Helps to contrast for this food has not been the free radicals action substantiated. Helps to restore intacellular antioxidants (e.i. glutathione) Is an antioxidant that Non-compliance with the Regulation protection of DNA, 2011;9(4):2021 protects the bodys because on the basis of the scientific proteins and lipids from cells. evidence assessed, this claimed effect oxidative damage Can protect you from for this food has not been free radicals. substantiated. Can protect your cells and tissues from oxidation. Can contribute to the total antioxidant capacity of the body. Protects the body's cells. Is believed to play a role Non-compliance with the Regulation alleviation of 2011;9(6):2273 in stress situation e.g. because on the basis of the scientific psychological stress helps to keep normal or evidence assessed, this claimed effect slightly increased blood for this food has not been pressure in critical substantiated. situations helps to calm and harmonize mind helps organism to adapt for emotional stress, physical effort

Non-authorised

1434

Non-authorised

1460

Non-authorised

656

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Nutrient, substance, food or food category

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Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Honey comb

It has a positive effect on improving health. It has a positive effect on memory and the ability to learn. It is beneficial during menopause.

Art.13(1) Arginine

Art.13(1) Arginine

Art.13(1) Arginine

Art.13(1) Arginine

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. It has positive effects on Non-compliance with the Regulation Normal red blood cell muscle integrity and on because on the basis of the scientific formation haematopoiesis (for red evidence assessed, this claimed effect blood cells building) for this food has not been substantiated. It has positive effects on Non-compliance with the Regulation growth or maintenance muscle integrity and on because on the basis of the scientific of muscle mass haematopoiesis (for red evidence assessed, this claimed effect blood cells building) for this food has not been substantiated. It has positive effects on Non-compliance with the Regulation Normal red blood cell muscle integrity and on because on the basis of the scientific formation haematopoiesis (for red evidence assessed, this claimed effect blood cells building). for this food has not been substantiated. It has positive effects on Non-compliance with the Regulation growth or maintenance muscle integrity and on because on the basis of the scientific of muscle mass haematopoiesis (for red evidence assessed, this claimed effect blood cells building). for this food has not been substantiated.

2010;8(2):1484

Non-authorised

3188, 3189

2011;9(4):2051

Non-authorised

456

2011;9(4):2051

Non-authorised

456

2011;9(4):2051

Non-authorised

1712

2011;9(4):2051

Non-authorised

1712

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Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamins, minerals, lysine and/or arginine and/or taurine (Pharmaton Kiddi)

It helps to support an Non-compliance with the Regulation not validated adequate because on the basis of the scientific vitamins/minerals/lysine evidence assessed, this food is not supplementation in sufficiently characterised for a children, in case of scientific assessment of this claimed unbalanced or effect and the claim could not therefore insufficient nutrition be substantiated. To support a healthy growth and development in children. When a child is recovering from illness, or has a loss of appetite. Art.13(1) Teanine It heps relaz status Non-compliance with the Regulation improvement of without reducing the because on the basis of the scientific cognitive function alert status; It hepls evidence assessed, this claimed effect against nervous tension for this food has not been substantiated. Art.13(1) Lysine It improves liver Non-compliance with the Regulation Increase in appetite function. because on the basis of the scientific leading to an increase To stimulates the evidence assessed, this claimed effect in energy intake appetite in a natural for this food has not been way substantiated. Art.13(1) Egg shell, crushed, without It maintains the good Non-compliance with the Regulation maintenance of normal membrane condition of bonesIt because on the basis of the scientific hair and nails protects and nourishes evidence assessed, this claimed effect bones, it is a suitable for this food has not been source of calcium for substantiated. bone restoration.

2011;9(4):2083

Non-authorised

2011;9(6):2238

Non-authorised

1707

2011;9(4):2063

Non-authorised

610

2010;8(10):1725

Non-authorised

3155

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Royal jelly, lyophilized

Art.13(1) Royal jelly, lyophilized

Art.13(1) Lecithin

Art.13(1) Lecithin

It nourishes the human body and supplies energy. It supplies vitamins and minerals from natural sources. It has positive effects during menopause and for overall rejuvenation of the skin and human body. It nourishes the human body and supplies energy. It supplies vitamins and minerals from natural sources. It has positive effects during menopause and for overall rejuvenation of the skin and human body. It promotes the correct function of the nervous system. To maintain optimal mental and cognitive performance. It promotes the correct function of the nervous system. To maintain optimal mental and cognitive performance.

Non-compliance with the Regulation "stimulant" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1738

Non-authorised

3190

Non-compliance with the Regulation immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1799

Non-authorised

3191

Non-compliance with the Regulation contribution to normal because on the basis of the scientific cognitive function evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation contribution to normal because on the basis of the scientific neurological function evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1741

Non-authorised

1596

2010;8(10):1741

Non-authorised

1596

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Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Taurine

Art.13(1) Taurine

Art.13(1) Yeo Valley yoghurt products containing the probiotic bacteria Bifidobacterium animalis ssp. lactis BB-12 and Lactobacillus acidophilus LA-5

It protects eye retina, for Non-compliance with the Regulation maintenance of normal 2011;9(4):2035 protection of liver cells because on the basis of the scientific cardiac function from toxins, for proper evidence assessed, this claimed effect heart function, proper for this food has not been cardio-vascular health substantiated. It supports proper Non-compliance with the Regulation metabolism processes2011;9(4):2035 metabolism (uptake of because on the basis of the scientific glucose/caffeine). evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Its Bio-Live. Each Non-compliance with the Regulation not validated 2009;7(9):1247 spoonful contains because on the basis of the scientific millions of bacteria that evidence assessed, this food is not help to maintain the sufficiently characterised for a balance of natural flora scientific assessment of this claimed in your body, which can effect and the claim could not therefore aid digestion and be substantiated. general well-being. Helps to maintain harmony in your digestive system Helps to maintain a healthy d

Non-authorised

1661

Non-authorised

613

Non-authorised

942

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Jerusalem artichoke

Jerusalem artichoke Non-compliance with the Regulation breaking down lactose 2009;7(9):1292 supports the digestive because on the basis of the scientific system so that the evidence assessed, this claimed effect stomach is calmed, food for this food has not been is well digested and one substantiated. obtains a light feeling. Prebiotic inulin maintains the guts population of beneficial bacteria so that the stomach remains in good shape. The inulin in Jerusalem artichoke supports the guts population of beneficial bacteria. Promotes lactose absorption.

Non-authorised

2819

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Jerusalem artichoke

Art.13(1) Oats beta-glucan

Jerusalem artichoke Non-compliance with the Regulation decreasing potentially 2009;7(9):1292 supports the digestive because on the basis of the scientific pathogenic intestinal system so that the evidence assessed, this claimed effect microorganisms stomach is calmed, food for this food has not been is well digested and one substantiated. obtains a light feeling. Prebiotic inulin maintains the guts population of beneficial bacteria so that the stomach remains in good shape. The inulin in Jerusalem artichoke supports the guts population of beneficial bacteria. Promotes lactose absorption. Kaera kiudaine beeta- Non-compliance with the Regulation digestive function 2011;9(6):2207 glkaani tarbimine because on the basis of the scientific soodustab seedimist. evidence assessed, this claimed effect Kaera kiudaine beeta- for this food is not sufficiently defined glkaani tarbimine aitab to be able to be assessed and the soodustada seedimist. claim could not therefore be Clarification provided substantiated. Consuming beta-glucan promotes digestion, improves digestive function.

Non-authorised

2819

Non-authorised

850

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Oats beta-glucan

Art.13(1) Kaki

Kaera kiudaine beeta- Non-compliance with the Regulation increase in satiety 2011;9(6):2207 glkaani tarbimine because on the basis of the scientific leading to a reduction in suurendab evidence assessed, this claimed effect energy intake kllastustunnet ehk for this food has not been tiskhutunnet.Kaera substantiated. kiudaine beeta-glkaani tarbimine pikendab kllastustunde ehk tiskhutunde silimist. Clarification provided Consuming oats betaglucan increases satiety. Consuming oats beta-glucan prolongs the feeling of satiety. Kaki is a major dietary Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 source of antioxidants because on the basis of the scientific proteins and lipids from Antioxidants from evidence assessed, this claimed effect oxidative damage dietary sources for this food has not been contribute to the substantiated. protection against free radicals which cause cell damage Contributes to the protection of cells and tissues from oxidative damage Help strengthen our body's natural defences against oxidative stress

Non-authorised

851

Non-authorised

1260

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Kaki

Art.13(1) Carbohydrates in pasta products

Kaki is a major source Non-compliance with the Regulation maintenance of vision 2009;7(9):1275 of carotanoids. because on the basis of the scientific Carotanoids from evidence assessed, this claimed effect dietary sources help for this food has not been maintain healthy eyes Is substantiated. a constituent of the macular pigment/macula lutea of the retina Helps to protect the retina and lens from oxidation Kolhydrater i pasta ger Non-compliance with the Regulation not validated 2011;9(4):2082 ett lgt och lngsamt because on the basis of the scientific blodsockersvar/har ett evidence assessed, this food is not lgt glykemiskt index sufficiently characterised for a (GI). scientific assessment of this claimed Carbohydrates in pasta effect and the claim could not therefore products provide a low be substantiated. and slow blood sugar response/have a low glycaemic index (GI).

Non-authorised

1261

Non-authorised

1171

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-Methionine

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

L-Methionine is an Non-compliance with the Regulation maintenance of normal essential amino acid because on the basis of the scientific blood cholesterol required for normal evidence assessed, this claimed effect concentrations growth and for this food has not been development in humans substantiated. and which enhances protein quality in cereals. .It helps physical development of infants and prevents build-up of bad cholesterol. L-Arginine L-arginine helps to Non-compliance with the Regulation Maintenance of normal induce and improve because on the basis of the scientific erectile function erection. evidence assessed, this claimed effect for this food has not been substantiated. L-Arginine L-arginine influence Non-compliance with the Regulation Contribution to normal positively on because on the basis of the scientific spermatogenesis spermatogenesis evidence assessed, this claimed effect (sperms formation and for this food has not been mobility). substantiated. Essential fatty acid Linoleic LA acid contributes to Non-compliance with the Regulation Maintenance of Acid (LA - omega 6) mental and cognitive because on the basis of the scientific neurological function development evidence assessed, this claimed effect for this food has not been substantiated. Essential fatty acid LA acid contributes to Non-compliance with the Regulation Maintenance of Linoleic Acid (LA - omega mental and cognitive because on the basis of the scientific neurological function 6) development. evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1744

Non-authorised

2913

2011;9(4):2051

Non-authorised

649

2011;9(4):2051

Non-authorised

650

2010;8(2):1485

Non-authorised

2897

2010;8(2):1485

Non-authorised

732

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Essential fatty acid LNA contributes to the Alpha-linolenic acid (LNA - good balance in omega 3) essential fatty acids in the diet and as such helps to maintain a strong body defense (system) Art.13(1) Lactobacillus delbrueckii La miscela aiuta a P18805 modulare la naturale risposta immunitaria.

Non-compliance with the Regulation Treatment of diseases because on the basis of the scientific evidence assessed, this claimed effect attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. Non-compliance with the Regulation Reduction in numbers because on the basis of the scientific of circulating CD34+ evidence assessed, this claimed effect cells for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Lactobacillus acidophilus P La miscela aiuta a Non-compliance with the Regulation Reduction in numbers 18806 rinforzare le naturali because on the basis of the scientific of circulating CD34+ difese immunitarie. evidence assessed, this claimed effect cells for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Streptococcus La miscela coadiuva la Non-compliance with the Regulation Reduction in numbers thermophilus P18807 maturazione del because on the basis of the scientific of circulating CD34+ sistema immunitario, evidence assessed, this claimed effect cells soprattutto nei soggetti for this food is not a beneficial sensibili a reazioni physiological effect as required by the allergiche. Regulation.

2011;9(4):2061

Non-authorised

500

2009;7(9):1247, 2012;10(8):2855

Non-authorised 2952 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2855

Non-authorised 2947 (expiry of transitional period 02/01/2014)

2010;8(2):1470, 2012;10(8):2855

Non-authorised 2975 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus P La miscela favorisce Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, 18806 l'equilibrio because on the basis of the scientific pathogenic gastro2012;10(8):2855 dell'ecosistema evidence assessed, this claimed effect intestinal intestinale. La miscela for this food has not been microorganisms regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

Non-authorised 2946 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus P La miscela favorisce Non-compliance with the Regulation Improved lactose 18806 l'equilibrio because on the basis of the scientific digestion dell'ecosistema evidence assessed, this claimed effect intestinale. La miscela for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

2009;7(9):1247, 2012;10(8):2855

Non-authorised 2946 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus acidophilus P La miscela favorisce Non-compliance with the Regulation Reduction of gastro18806 l'equilibrio because on the basis of the scientific intestinal discomfort dell'ecosistema evidence assessed, this claimed effect intestinale. La miscela for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

2009;7(9):1247, 2012;10(8):2855

Non-authorised 2946 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus delbrueckii P18805

La miscela favorisce Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, l'equilibrio because on the basis of the scientific pathogenic gastro2012;10(8):2855 dell'ecosistema evidence assessed, this claimed effect intestinal intestinale. La miscela for this food has not been microorganisms regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

Non-authorised 2951 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus delbrueckii P18805

La miscela favorisce Non-compliance with the Regulation Improved lactose l'equilibrio because on the basis of the scientific digestion dell'ecosistema evidence assessed, this claimed effect intestinale. La miscela for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

2009;7(9):1247, 2012;10(8):2855

Non-authorised 2951 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus delbrueckii P18805

La miscela favorisce Non-compliance with the Regulation Reduction of gastrol'equilibrio because on the basis of the scientific intestinal discomfort dell'ecosistema evidence assessed, this claimed effect intestinale. La miscela for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

2009;7(9):1247, 2012;10(8):2855

Non-authorised 2951 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus thermophilus P18807

La miscela favorisce Non-compliance with the Regulation Decreasing potentially 2010;8(2):1470, l'equilibrio because on the basis of the scientific pathogenic gastro2012;10(8):2855 dell'ecosistema evidence assessed, this claimed effect intestinal intestinale. La miscela for this food has not been microorganisms regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

Non-authorised 2974 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus thermophilus P18807

La miscela favorisce Non-compliance with the Regulation Improved lactose l'equilibrio because on the basis of the scientific digestion dell'ecosistema evidence assessed, this claimed effect intestinale. La miscela for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio.

2010;8(2):1470, 2012;10(8):2855

Non-authorised 2974 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus thermophilus P18807

Art.13(1) Lactoferrin

Art.13(1) Lactose;(milk sugar)

La miscela favorisce Non-compliance with the Regulation Reduction of gastro2010;8(2):1470, l'equilibrio because on the basis of the scientific intestinal discomfort 2012;10(8):2855 dell'ecosistema evidence assessed, this claimed effect intestinale. La miscela for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. La miscela influisce positivamente sul benessere dell'organismo. La miscela ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. La miscela utili nella digestione del lattosio. Lactoferin favourably Non-compliance with the Regulation Prevention or treatment 2011;9(6):2228 affect skin because on the basis of the scientific of acne status/improve external evidence assessed, this claimed effect skin status attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. Lactose can help the Non-compliance with the Regulation increase in calcium 2011;9(6):2234 absorption of calcium in because on the basis of the scientific absorption leading to the body. evidence assessed, this claimed effect an increase in calcium for this food has not been retention substantiated.

Non-authorised 2974 (expiry of transitional period 02/01/2014)

Non-authorised

3164

Non-authorised

668

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Aliments contenant du Magnsium

Art.13(1) Bta-carotne

Art.13(1) magnsium

Art.13(1) Graines de brocoli et extraits de graines de brocoli : Sulforaphane

Art.13(1) Graines de brocoli et extraits de graines de brocoli

Art.13(1) Lecithin

Le Magnsium vous Non-compliance with the Regulation Resistance to mental 2010;8(10):1807 aide lutter contre les because on the basis of the scientific stress petits stress quotidiens evidence assessed, this claimed effect for this food has not been substantiated. Le bta-carotne Non-compliance with the Regulation protection of the skin 2011;9(4):2021 favorise lapparition du because on the basis of the scientific from UV-induced bronzage en apportant evidence assessed, this claimed effect (including photoune lgre coloration de for this food has not been oxidative) damage la peau substantiated. Le magnsium est Non-compliance with the Regulation maintenance of normal 2010;8(10):1807 essentiel au because on the basis of the scientific fat metabolism mtabolisme des evidence assessed, this claimed effect lipides. for this food has not been substantiated. Le sulforaphane aide Non-compliance with the Regulation Prevention or treatment 2011;9(6):2228 maintenir la fonction de because on the basis of the scientific of prostate cancer la prostate. Il contribue evidence assessed, this claimed effect la fonction normale de attributes to this food the property of la prostate. Il aide preventing, treating or curing a human maintenir votre prostate disease, or refers to such properties en forme which is prohibited for foods. Le sulforaphane aide Non-compliance with the Regulation reduction of gastro2011;9(6):2248 maintenir la sant because on the basis of the scientific intestinal discomfort gastro-intestinale. Il evidence assessed, this claimed effect apporte un effet for this food has not been bnfique sur la sant substantiated. gastro-intestinale. Lecithin (a phospholipid Non-compliance with the Regulation contribution to normal 2010;8(10):1741 containing choline) because on the basis of the scientific cognitive function supports memory and evidence assessed, this claimed effect concentration. for this food has not been substantiated.

Non-authorised

375

Non-authorised

1968

Non-authorised

378

Non-authorised

2773

Non-authorised

3193

Non-authorised

1983

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lecithin

Lecithin helps to maintain normal function of cardovascular system.

Art.13(1) Aliments sources de glucides complexes

Art.13(1) Long Chain Fatty Acids (EPA/DHA)

Art.13(1) Marine oils such as cod liver oil and fish oil containing eicosapentaenoic acid (EPA : C20:5 n-3) + docosahexaenoic acid (DHA; C22:6 n-3) or longchain n-3 (omega 3) polyunsaturated fatty acids (LC n-3 PUFA, LC omega 3 PUFA) or Omega 3

Non-compliance with the Regulation maintenance of normal because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Les glucides complexes Non-compliance with the Regulation not validated contribuent la satit. because on the basis of the scientific De lnergie durant la evidence assessed, this food is not matine grce aux sufficiently characterised for a glucides complexes scientific assessment of this claimed Clarification provided effect and the claim could not therefore complex carbohydrates be substantiated. contribute to satiety complex carbohydrates help keep you fuller for longer" Long tradition of use in Non-compliance with the Regulation maintenance of joints helping joint mobility. because on the basis of the scientific Renowned for helping evidence assessed, this claimed effect maintain Joint Mobility for this food has not been and Flexibility substantiated. Long-chain Omega 3 Non-compliance with the Regulation maintenance of joints polyunsaturated fatty because on the basis of the scientific acids help maintain evidence assessed, this claimed effect healthy, flexible, mobile for this food has not been and supple joints substantiated.

2010;8(10):1741

Non-authorised

3187

2011;9(4):2082

Non-authorised

602

2009;7(9):1263

Non-authorised

518

2009;7(9):1263

Non-authorised

505

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Long chain omega-3 fatty Long-chain omega-3 acids EPA and DHA fatty acids EPA and DHA help maintain healthy levels of good cholesterol. Normal levels of good cholesterol are important for keeping your heart and blood vessels healthy. Longchain omega-3 fatty acids EPA and DHA help maintain normal cholesterol levels. Art.13(1) Rye fibre Long-lasting energy. Levels out the blood sugar increase after meals. Low glycemic index. Art.13(1) Carbohydrates with a low Low GI carbohydrates glycaemic index (GI) sustain steady blood sugar levels.

Non-compliance with the Regulation maintenance of normal 2009;7(9):1263 because on the basis of the scientific HDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

515

Non-compliance with the Regulation reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2258

Non-authorised

826

2010;8(2):1491

Non-authorised

480

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrates with a low Low GL foods help keep Non-compliance with the Regulation not validated glycaemic load you fuller for longer because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Carbohydrates that induce Low glycaemic Non-compliance with the Regulation not validated a low glycaemic response carbohydrates / low because on the basis of the scientific glycaemic evidence assessed, this food is not [carbohydrate] diet sufficiently characterised for a helps maintain and scientific assessment of this claimed improve blood glucose effect and the claim could not therefore control; Low glycaemic be substantiated. carbohydrates / low glycaemic [carbohydrate] diet helps in the management of regular blood glucose levels; Low glycaemic carbohydrates / low glycaemic [carbohydrate] diet supports body weight regulation; Low glycaemic carbohydrates / low glycaemic[carbohydrate ] diet contributes to weight control.

2011;9(4):2082

Non-authorised

478

2010;8(2):1491

Non-authorised

474

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Very low calorie diet (VLCD) Programme

Low glycaemic index formula food Low glycamic index products

Art.13(1) Fructose + dextrose

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Low-calorie and filling Non-compliance with the Regulation contribution to the snack. because on the basis of the scientific maintenance or Slow carbohydrates evidence assessed, this claimed effect achievement of a prevent rapid changes for this food has not been normal body weight in blood sugar. substantiated. Slow carbohydrates help to keep blood sugar levels even for a long time. With no rapid drops in blood sugar people feel more satiated, due to which weight control is easier. Fibre-rich food is good for those wanting to lose weight. Fibre does not contain energy, but is filling.

2011;9(6):2271

Non-authorised

1414

2011;9(6):2246

Non-authorised

559

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructose + dextrose

Low-calorie and filling snack. Slow carbohydrates prevent rapid changes in blood sugar. Slow carbohydrates help to keep blood sugar levels even for a long time. With no rapid drops in blood sugar people feel more satiated, due to which weight control is easier. Fibre-rich food is good for those wanting to lose weight. Fibre does not contain energy, but is filling. Art.13(1) Essential amino acids: 25 Lowers cholesterol mg lysine chloride. levels

Non-compliance with the Regulation reduction of postbecause on the basis of the scientific prandial glycaemic evidence assessed, this claimed effect responses for this food has not been substantiated.

2011;9(6):2246

Non-authorised

559

Art.13(1) Hippophae rhamnoidesberry-oil-Sea buckthorn berry oil

Lowers the ageing process.

Non-compliance with the Regulation maintenance of normal 2011;9(4):2063 because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Non-compliance with the Regulation protection of cells from 2010;8(10):1752 because on the basis of the scientific premature aging evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

4669

Non-authorised

4415

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein Lutein helps maintain a (example from tagetes E or healthy vision Calendula Officinalis) Luteinfor maintenance of a healthy sight Luteinfor maintenance of healthy eyes

Non-compliance with the Regulation maintenance of normal 2011;9(4):2030 because on the basis of the scientific vision evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food.

Non-authorised

2080

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lutein

Lutein promotes healthy Non-compliance with the Regulation Maintenance of vision 2010;8(2):1492 eye function. Lutein and because on the basis of the scientific zeaxanthin help protect evidence assessed, the evidence the retina against provided is insufficient to substantiate oxidation / from this claimed effect for this food. oxidative stress. Lutein is a constituent of the macular pigment. Lutein and zeaxanthin are deposited naturally in the macula and lens. Lutein and zeaxanthin are highly and selectively accumulated in the macula and lens / in the retina Lutein contributes to eye health. Lutein helps maintain the normal function of the macula. Lutein contributes to a healthy macula and retina. Lutein nutrition for the eyes. Lutein contributes to the protection of vision. Lutein is important for macular pigment density. Lutein and zeaxanthin help protect the retina against oxidation / from

Non-authorised

1931

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lycopene (fromTomato extract)

oxidative stress. Lutein und zeaxanthin are natural antioxidants for the eye. Lutein helps fight free radicals in the eye. Lutein and zeaxanthin are natural filters of visible blue light. Lutein and zeaxanthin help protect the eye against harmful effects of light exposure. Lutein help protect the eye against visible light damage Lycopene from tomato extract has an antioxidant effect. Lycopenes contained in this product have an antioxidant action/ ensure a protective effect on the organism/contribute to the protection of the cellular membranes from oxidation.

Non-compliance with the Regulation protection of DNA, 2011;9(4):2031 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

2081

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lycopene

Art.13(1) Lycopenes from tomato juices

Art.13(1) L-Lysine

Art.13(1) Lysine

Lycopenes contained in Non-compliance with the Regulation protection of DNA, this product ensure because on the basis of the scientific proteins and lipids from antioxidant action. evidence assessed, this claimed effect oxidative damage Ensure protective effect for this food has not been on the organism. substantiated. Contribute to the protection of the cellular membranes from oxidation. Lycopenes contained in Non-compliance with the Regulation protection of DNA, this product ensure because on the basis of the scientific proteins and lipids from antioxidant evidence assessed, this claimed effect oxidative damage action/lycopenes for this food has not been contained in this substantiated. product ensure protective effect on the organism; antioxidant/s. Lysine can contribute to Non-compliance with the Regulation Maintenance of normal the development and because on the basis of the scientific bone maintenance of the evidence assessed, this claimed effect normal structure of for this food has not been bones. substantiated. Lysine is an essential Non-compliance with the Regulation Contribution to normal amino acid that is because on the basis of the scientific protein synthesis necessary for evidence assessed, this claimed effect maintenance of the for this food has not been body/body tissues/body substantiated. function. Addition of lysine enhances of cereal protein quality

2011;9(4):2031

Non-authorised

1608

2011;9(4):2031

Non-authorised

1611

2011;9(4):2063

Non-authorised

663, 1915

2011;9(4):2063

Non-authorised

1612

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lysine

Art.13(1) Lysine

Lysine is an essential amino acid that is necessary for maintenance of the body/body tissues/body function. Addition of lysine enhances of cereal protein quality Lysine supports the cardiovascular system functions.

Non-compliance with the Regulation Increase in calcium 2011;9(4):2063 because on the basis of the scientific absorption leading to evidence assessed, this claimed effect an increase in calcium for this food has not been retention substantiated.

Non-authorised

1612

Art.13(1) Lysine

Art.13(1) MSM methylsulfonylmetan

Art.13(1) Methylsulfonylmethane

Non-compliance with the Regulation maintenance of normal because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Lysine supports the Non-compliance with the Regulation Immune defence immune systems because on the basis of the scientific against herpes virus functions evidence assessed, this claimed effect for this food has not been substantiated. MSM is important for Non-compliance with the Regulation strengthens the the immune system because on the basis of the scientific immune system evidence assessed, this claimed effect function attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. MSM might be Non-compliance with the Regulation contribution to normal supportive for the bone because on the basis of the scientific collagen formation and joints health evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2063

Non-authorised

454

2011;9(4):2063

Non-authorised

453

2010;8(10):1746

Non-authorised

390

2010;8(10):1746

Non-authorised

389

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) MSM methylsulfonylmetan

Art.13(1) MSM Methylsulfonylmethan

Art.13(1) MSM methylsulfonylmetan

MSM might support the healthy development and function of stomach, positively affect digestion, might also rejuvenate the peristaltics of intestines MSM nourishes joints and helps in synthesis of collagen in joint cartilage. It has positive effect on teeth, nails, hair and bones. MSM supports the synthesis of metion and cystein, might have a detoxication effects

Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 because on the basis of the scientific bowel function evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

391

Non-compliance with the Regulation contribution to normal because on the basis of the scientific collagen formation evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1746

Non-authorised

394

Art.13(1) Magnesium

Non-compliance with the Regulation contribution to the 2010;8(10):1746 because on the basis of the scientific normal cysteine evidence assessed, this claimed effect synthesis for this food has not been substantiated. Magnesium contributes Non-compliance with the Regulation Maintenance of normal 2010;8(10):1807 to meeting the because on the basis of the scientific blood pressure during increased requirement evidence assessed, this claimed effect pregnancy for magnesium in for this food has not been pregnant women, so it substantiated. could help the normal course of pregnancy and delivery and birth of a healthy baby.

Non-authorised

392

Non-authorised

367

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Magnesium

Art.13(1) Magnesium

Magnesium contributes to the maintenance of hormonal health Magnesium helps to maintain hormonal health. Magnesium is an essential co-factor in fatty acid metabolism which impacts on hormonal health. Magnesium has antioxidative properties It prolongs the ageing process

Non-compliance with the Regulation Hormonal health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1807

Non-authorised

243

Art.13(1) Magnesium

Art.13(1) Magnesium

Non-compliance with the Regulation protection of DNA, 2010;8(10):1807 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Magnesium is Non-compliance with the Regulation blood coagulation 2009;7(9):1216 necessary for normal because on the basis of the scientific blood clotting evidence assessed, this claimed effect for this food has not been substantiated. Magnesium maintains Non-compliance with the Regulation maintenance of the 2010;8(10):1807 healthy immune system because on the basis of the scientific normal function of the evidence assessed, this claimed effect immune system for this food has not been substantiated.

Non-authorised

351

Non-authorised

357

Non-authorised

352

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Huile de foie de morue : Maintain the youth Cod liver oil standardized incapital of the skin. vitamin A, EPE and HA Contribute to the integrity of the skin tissues

Non-compliance with the Regulation Skin health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lactobacillus johnsonii BFEMaintains/restores the Non-compliance with the Regulation decreasing potentially 6128 balance of intestinal because on the basis of the scientific pathogenic intestinal flora Promotes intestinal evidence assessed, this claimed effect microorganisms comfort Strengthens for this food has not been resistance of organism substantiated. Improves digestive health the natural defences; help/contribute/participa te to strengthen the immune system. Art.13(1) Cocoa flavanols Maintenance and Non-compliance with the Regulation maintenance of normal promotion of a normal because on the basis of the scientific blood pressure blood pressure evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food. Art.13(1) Aronia melanocarpa Maintenance of blood Non-compliance with the Regulation Vascular and vein (Common Name : vessel wals strenght because on the basis of the scientific health Chokeberry ) evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

4243

2009;7(9):1239

Non-authorised

989

2010;8(10):1792

Non-authorised

1507

2011;9(6):2228

Non-authorised

1998

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soy Isoflavones

Art.13(1) Hydrolysat de chitosan

Maintenance of healty bones /(natural) /support to bone health /contributes to the maintenance of normal bone strength in postmenopausal women Maintien de la flexibilit articulaire Aide au maintien de la sant articulaire Bien-tre articulaire

Non-compliance with the Regulation Maintenance of bone because on the basis of the scientific mineral density evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food.

2009;7(9):1270, 2012;10(8):2847

Non-authorised 1655 (expiry of transitional period 02/01/2014)

Art.13(1) L-carnitine

Makes energy metabolism more effective. Protects cell energy metabolism. Reduces changes in energy metabolism caused by ageing. Art.13(1) Polyphenols and vitamins Makes smoother and Non-compliance with the Regulation antioxidant and antifrom pomegranate extract softer skin. because on the basis of the scientific aging properties Diminishes appearance evidence assessed, this claimed effect of fine lines and for this food is not sufficiently defined wrinkles. to be able to be assessed and the Increases skin hydration claim could not therefore be and suppleness. substantiated. Gives skin wellness and youthful appearance. Stimulates cell repair.

Non-compliance with the Regulation reduction of because on the basis of the scientific inflammation evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation. Non-compliance with the Regulation energy metabolism because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2214

Non-authorised

1985

2011;9(6):2212

Non-authorised

1821

2010;8(10):1750

Non-authorised

1901

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Phospolipids

Art.13(1) Malic acid

Art.13(1) Maltodextrin

Art.13(1) Mangosteen (Garcinia mangostana L) fruits and extracts derived from the fruits

Art.13(1) Mangosteen (Garcinia mangostana L) fruits and extracts derived from the fruits

Makes the immune Non-compliance with the Regulation protection of DNA, defence system more because on the basis of the scientific proteins and lipids from effective and repairs evidence assessed, this claimed effect oxidative damage oxidation damage of for this food has not been cells. substantiated. Malic acid is needed for Non-compliance with the Regulation contribution to normal proper functioning of the because on the basis of the scientific energy-yielding energy cycle evidence assessed, this claimed effect metabolism for this food has not been substantiated. Maltodextrin releases Non-compliance with the Regulation Physical performance energy slowly and because on the basis of the scientific equally. evidence assessed, this claimed effect for this food is not sufficiently defined Releases energy in to be able to be assessed and the stages and easily. claim could not therefore be substantiated. Mangosteen whole fruit Non-compliance with the Regulation Reduction of juice/concentrate because on the basis of the scientific inflammation [contains xanthones evidence assessed, this claimed effect which] may help for this food is not a beneficial regulate antiphysiological effect as required by the inflammatory responses Regulation. [in the body] Mangosteen whole fruit Non-compliance with the Regulation maintenance of normal juice/concentrate because on the basis of the scientific blood LDL-cholesterol [contains xanthones evidence assessed, this claimed effect concentrations which] may help to for this food has not been regulate blood lipids substantiated.

2009;7(9):1246

Non-authorised

1834

2011;9(6):2247

Non-authorised

1613

2011;9(6):2228

Non-authorised

560

2011;9(4):2061

Non-authorised

2862

2011;9(6):2246

Non-authorised

2861

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Mangosteen (Garcinia mangostana L) fruits and extracts derived from the fruits

Non-compliance with the Regulation Immune 2011;9(4):2061 because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Mangosteen (Garcinia Mangosteen whole fruit Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 mangostana L) fruits and juice/concentrate because on the basis of the scientific proteins and lipids from extracts derived from the contains antioxidants evidence assessed, this claimed effect oxidative damage fruits - [which may neutralise for this food has not been the damaging effects of substantiated. free radicals in the body] - [which contribute to the total antioxidant capacity within the body] - [which offer protection from oxidative effects/damage within the body Art.13(1) Chios Mastiha Natural resinMastiha Chiou has an Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 Protected Designation of antioxidant action. because on the basis of the scientific content, and antioxidant Origin product. (PDO) evidence assessed, this claimed effect properties (EC)123/1997 for this food is not a beneficial (L022/24.1.97) physiological effect as required by the Regulation.

Mangosteen whole fruit juice/concentrate [contains xanthones which] may help to support the immune system

Non-authorised

2859

Non-authorised

2860

Non-authorised

1315

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Long-chain Omega-3 fatty Maternal Health; Non-compliance with the Regulation Maternal health; 2011;9(4):2078 acids EPA and DHA Pregnancy and nursing because on the basis of the scientific pregnancy and nursing Clarification provided evidence assessed, this claimed effect The omega-3 fatty acids for this food is not sufficiently defined EPA and DHA help to be able to be assessed and the sustain pregnancy claim could not therefore be duration. Consumption substantiated. of long chain omega-3 fatty acids increases breast milk DHA levels during nursing.Consumption of long chain omega-3 fatty acids during pregnancy and nursing increases the mothers DHA stores. Maternal consumption of EPA and DHA during pregnancy may support neural and visual development in the unborn baby. Art.13(1) Omega-3 fish body oil May help maintain a Non-compliance with the Regulation "Skin and digestive 2011;9(4):2078 PUFAs healthy digestive because on the basis of the scientific tract epithelial cells system Gentle on the evidence assessed, this claimed effect maintenance stomach Appearance of for this food is not sufficiently defined skin, healthy looking to be able to be assessed and the skin, a part of your daily claim could not therefore be skin care routine, helps substantiated. maintain a good complexion.

Non-authorised

514

Non-authorised

525

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Grapefruit (Citrus paradisi May help the Mact. = C. decumana L., C.detoxification process. grandis Osbeck ; Citrus Possesses antioxidant maxima) activity. Can be considered as a detoxifying / purifying agent, due to its antioxidant properties. Provides antioxidant protection. Art.13(1) Citrus bioflavonoids May help to keep joints healthy.

Non-compliance with the Regulation antioxidant activity, 2010;8(10):1752 because on the basis of the scientific antioxidant content, and evidence assessed, this claimed effect antioxidant properties for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

2728

Art.13(1) Alfalfa

Non-compliance with the Regulation Maintenance of joints because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. May help to reduce LDL Non-compliance with the Regulation not validated cholesterol. For because on the basis of the scientific cardiovascular health. evidence assessed, this food is not Clarification provided sufficiently characterised for a May help to reduce LDL scientific assessment of this claimed cholesterol. For effect and the claim could not therefore cardiovascular health. be substantiated.

2010;8(2):1493

Non-authorised

1799

2011;9(4):2082

Non-authorised

2793

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Phosphatidylserine

May improve memory in Non-compliance with the Regulation not validated the elderly because on the basis of the scientific May improve cognitive evidence assessed, this food is not performance in the sufficiently characterised for a elderly scientific assessment of this claimed May improve memory effect and the claim could not therefore and cognitive be substantiated. performance in the elderly PS is a naturally occurring phospholipid (lecithin) present in all cells. It is most concentrated in the brain where it plays a role in healthy brain functions PS is essential to the functioning of all cells of the body, but is most concentrated in the brain and can help maintain healthy brain function PS is a food ingredient intended to support brain function

2010;8(10):1749

Non-authorised

711

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Phosphatidylserine

May improve memory in Non-compliance with the Regulation not validated the elderly because on the basis of the scientific May improve cognitive evidence assessed, this food is not performance in the sufficiently characterised for a elderly. scientific assessment of this claimed May improve memory effect and the claim could not therefore and cognitive be substantiated. performance in the elderly Support of cognitive functions in young people Contributes to the maintenance of cognitive functions with aging Supports memory and brain performance in aging adults Plays an important role in healthy nerve function through the central nervous system including the brain Contributes to the resistance against stress Helps concentration and mental performance in cases of stress

2010;8(10):1749

Non-authorised

552

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Methylsulfonylmethan (MSM)

Art.13(1) Zeolite - clinoptilolit

Art.13(1) Mucopolysaccharides

Methylsulfonylmethan is Non-compliance with the Regulation maintenance of joints important for the because on the basis of the scientific creation of collagen and evidence assessed, this claimed effect proper formation of for this food has not been cartilage and bone substantiated. tissue. Might help to protect the Non-compliance with the Regulation elimination of heavy body tissues and cells because on the basis of the scientific metals from oxidative damage, evidence assessed, this claimed effect viruses, heavy metals, for this food has not been toxines and free substantiated. radicals, alergenes and radionuclids. Might helps to keep normal level of blood cholesterol, lipid and sugar. Might be useful in increasing the bioavailability of vitamins, minerals and nutritive substances from food. Balances the pH level of organism and it might rejuvenate the intestine peristaltic. Mucopolysaccharides Non-compliance with the Regulation Maintenance of joints help maintaining healthy because on the basis of the scientific joints evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1268

Non-authorised

395

2010;8(10):1733

Non-authorised

3156

2010;8(2):1493

Non-authorised

3624

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-carnosine

Muscle power and endurance.

Art.13(1) L-carnosine

Art.13(1) Mycoprotein

Non-compliance with the Regulation increase in endurance 2011;9(4):2038 because on the basis of the scientific capacity evidence assessed, this claimed effect for this food has not been substantiated. Muscle power and Non-compliance with the Regulation increase in muscle 2011;9(4):2038 endurance. because on the basis of the scientific power evidence assessed, this claimed effect for this food has not been substantiated. Mycoprotein satisfies Non-compliance with the Regulation increase in satiety 2011;9(4):2042 your appetite for longer because on the basis of the scientific leading to a reduction in on fewer calories evidence assessed, this claimed effect energy intake for this food has not been substantiated.

Non-authorised

1824

Non-authorised

1824

Non-authorised

1620

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bonito protein peptide

Natural Blood Pressure Non-compliance with the Regulation maintenance of normal 2010;8(10):1730 Support because on the basis of the scientific blood pressure Provides peptides evidence assessed, this claimed effect isolated from bonito to for this food has not been support healthy blood substantiated. pressure levels. Provides effective levels of wellresearched, specific peptides for healthy blood pressure support. Formulated to promote healthy blood pressure levels already within the normal range A natural approach for blood pressure support Bioactive peptides isolated from bonito fish support blood pressure health naturally. Testing for LKPNM assures efficacy to help maintain blood pressure already within the normal range.

Non-authorised

1716

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Berries (lingonberry, cloudberry, blueberry, currants, raspberry and strawberry)

Art.13(1) Arabinoxylan

Natural berries contain plenty of natural antioxidants (polyphenolic compounds, Vitamin C and carotenoids) and fibre but only a small amount of energy and sodium. For this reason they are very suitable for a heart-friendly diet. Natural enhancer of immune system. Supports the immune system. Supports the immune response Support of the body's defence

Non-compliance with the Regulation protection of DNA, 2011;9(6):2246 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1184

Non-compliance with the Regulation Stimulation of natural because on the basis of the scientific killer cell activity evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation.

2011;9(6):2228

Non-authorised

3128

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Avocado-soy extract

Natural flexibility for the Non-compliance with the Regulation Maintenance of joints 2010;8(2):1493 joints. Accelerates the because on the basis of the scientific formation of new evidence assessed, this claimed effect cartilage by increasing for this food has not been the formation of substantiated. cartilage growth factors. Facilitates exercise. Activates the building of joint cartilage. Natural flexibility remains. Accelerates the formation of collagen in joint membrane cells (synoviocytes). Art.13(1) Omega-3 stable fish body Natural stable omega-3 Non-compliance with the Regulation maintenance of normal 2010;8(10):1796 oil fatty acids help to because on the basis of the scientific blood LDL-cholesterol maintain a healthy heart evidence assessed, this claimed effect concentrations for this food has not been substantiated. Art.13(1) Fish oil 2 Natural stable omega-3 Non-compliance with the Regulation maintenance of joints 2009;7(9):1263 N-3 (EPA, DHA) fatty acids help to because on the basis of the scientific maintain supple joints. evidence assessed, this claimed effect Natural stable omega-3 for this food has not been fatty acids help manage substantiated. anti-inflammatory responses.

Non-authorised

2794

Non-authorised

527

Non-authorised

535

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Omega-3 stable fish body Natural stable omega-3 Non-compliance with the Regulation maintenance of joints oil fatty acids help to because on the basis of the scientific maintain supple joints. evidence assessed, this claimed effect Natural stable omega-3 for this food has not been fatty acids help manage substantiated. anti-inflammatory responses. Art.13(1) Sulphur Natural sulphur, which Non-compliance with the Regulation contribution to normal helps build and renew because on the basis of the scientific collagen formation connective tissue, evidence assessed, this claimed effect reduce inflammation in for this food has not been joints and muscles substantiated. For healthy skin, hair and nails Ensures elasticity of connective tissues Improves the structure of skin, hair, nails and joints ArthroStop Plus contains substances necessary for cartilage formation and functioning of joints MSM help maintain joint functions MSM helps improve joint mobility Necessary for normal metabolism in joints

2009;7(9):1263

Non-authorised

526

2010;8(10):1746

Non-authorised

353

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sulphur

Natural sulphur, which Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 helps build and renew because on the basis of the scientific hair connective tissue, evidence assessed, this claimed effect reduce inflammation in for this food has not been joints and muscles substantiated. For healthy skin, hair and nails Ensures elasticity of connective tissues Improves the structure of skin, hair, nails and joints ArthroStop Plus contains substances necessary for cartilage formation and functioning of joints MSM help maintain joint functions MSM helps improve joint mobility Necessary for normal metabolism in joints

Non-authorised

353

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coenzyme Q10 (Ubiquinone);

Art.13(1) Water-ethanol extract of Caralluma fimbriata

Naturally occuring lipid soluble antioxidant in the body -helps to protect against lipid oxidation -antioxidant helps to maintain healthy condition -helps to protect against free radicals which are mainly responsible for cellular ageing Natures solution to help reduce you reduce your waist size

Non-compliance with the Regulation protection of DNA, 2010;8(10):1793 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1510

Art.13(1) Water-ethanol extract of Caralluma fimbriata

Art.13(1) Water-ethanol extract of Caralluma fimbriata

Art.13(1) Biotin

Non-compliance with the Regulation Ethanol-water extract of 2011;9(6):2203 because on the basis of the scientific Caralluma fimbriata and evidence assessed, this claimed effect reduction in waist for this food has not been circumference substantiated. Natures solution to help Non-compliance with the Regulation Ethanol-water extract of 2011;9(6):2203 reduce your appetite as because on the basis of the scientific Caralluma fimbriata and part of a healthy lifestyle evidence assessed, this claimed effect reduction of appetite for this food has not been substantiated. Natures solution to help Non-compliance with the Regulation Ethanol-water extract of 2011;9(6):2203 reduce your body because on the basis of the scientific Caralluma fimbriata and weight evidence assessed, this claimed effect reduction of body for this food has not been weight substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal 2010;8(10):1728 teeth, bones, hair, skin because on the basis of the scientific bone and nails evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

4191

Non-authorised

4193

Non-authorised

4192

Non-authorised

121

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Biotin

Art.13(1) Biotin

Art.13(1) Vitamin B12

Art.13(1) Vitamin B12

Art.13(1) Vitamin B12

Art.13(1) Vitamin B12

Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific nails and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific teeth and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific bone and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific hair and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific nails and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific skin and nails evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1728

Non-authorised

121

2010;8(10):1728

Non-authorised

121

2010;8(10):1756

Non-authorised

104

2010;8(10):1756

Non-authorised

104

2010;8(10):1756

Non-authorised

104

2010;8(10):1756

Non-authorised

104

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B12

Art.13(1) Vitamin E

Art.13(1) Vitamin E

Art.13(1) Vitamin E

Art.13(1) Vitamin E

Art.13(1) Vitamin E

Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific teeth and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific bone and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific hair and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific nails and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific skin and nails evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific teeth and nails evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1756

Non-authorised

104

2010;8(10):1816

Non-authorised

164

2010;8(10):1816

Non-authorised

164

2010;8(10):1816

Non-authorised

164

2010;8(10):1816

Non-authorised

164

2010;8(10):1816

Non-authorised

164

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin A

Art.13(1) Vitamin A

Art.13(1) Vitamin A

Art.13(1) Vitamin A

Art.13(1) Vitamin B1

Art.13(1) Vitamin B1

Necessary for healthy Non-compliance with the Regulation maintenance of bone teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of hair teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of nails teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of teeth teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of bone teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of hair teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1221

Non-authorised

17

2009;7(9):1221

Non-authorised

17

2009;7(9):1221

Non-authorised

17

2009;7(9):1221

Non-authorised

17

2009;7(9):1222

Non-authorised

25

2009;7(9):1222

Non-authorised

25

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B1

Art.13(1) Vitamin B1

Art.13(1) Vitamin B1

Art.13(1) Vitamin B2

Art.13(1) Vitamin B2

Art.13(1) Vitamin B2

Necessary for healthy Non-compliance with the Regulation maintenance of nails teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of skin teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of teeth teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific bone and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific hair and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific nails and nails. evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1222

Non-authorised

25

2009;7(9):1222

Non-authorised

25

2009;7(9):1222

Non-authorised

25

2010;8(10):1814

Non-authorised

33

2010;8(10):1814

Non-authorised

33

2010;8(10):1814

Non-authorised

33

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B2

Art.13(1) Vitamin B3

Art.13(1) Vitamin B3

Art.13(1) Vitamin B3

Art.13(1) Vitamin B3

Art.13(1) Vitamin B5

Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific teeth and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of bone teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of hair teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of nails teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of teeth teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of bone teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(10):1814

Non-authorised

33

2009;7(9):1224

Non-authorised

50

2009;7(9):1224

Non-authorised

50

2009;7(9):1224

Non-authorised

50

2009;7(9):1224

Non-authorised

50

2009;7(9):1218

Non-authorised

61

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B5

Art.13(1) Vitamin B5

Art.13(1) Vitamin B5

Art.13(1) Vitamin B5

Art.13(1) Vitamin B6

Art.13(1) Vitamin B6

Necessary for healthy Non-compliance with the Regulation maintenance of hair teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of nails teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of skin teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of teeth teeth, bones, hair, skin because on the basis of the scientific and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific bone and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific hair and nails. evidence assessed, this claimed effect for this food has not been substantiated.

2009;7(9):1218

Non-authorised

61

2009;7(9):1218

Non-authorised

61

2009;7(9):1218

Non-authorised

61

2009;7(9):1218

Non-authorised

61

2010;8(10):1759

Non-authorised

74

2010;8(10):1759

Non-authorised

74

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B6

Art.13(1) Vitamin B6

Art.13(1) Vitamin B6

Art.13(1) Gamma linolenic acid

Art.13(1) Wheat germ oil

Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific nails and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific skin and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for healthy Non-compliance with the Regulation maintenance of normal teeth, bones, hair, skin because on the basis of the scientific teeth and nails. evidence assessed, this claimed effect for this food has not been substantiated. Necessary for normal Non-compliance with the Regulation Contribution to normal growth, wholesome because on the basis of the scientific cognitive function mental and physical evidence assessed, this claimed effect development, a healthy for this food has not been nervous system, substantiated. maintenance of memory and cognitive abilities, particularly in old age Necessary for normal Non-compliance with the Regulation contribution to normal growth, wholesome because on the basis of the scientific cognitive function mental and physical evidence assessed, this claimed effect development, a healthy for this food has not been nervous system, substantiated. maintenance of memory and cognitive abilities, particularly in old age

2010;8(10):1759

Non-authorised

74

2010;8(10):1759

Non-authorised

74

2010;8(10):1759

Non-authorised

74

2011;9(4):2059

Non-authorised

1770

2010;8(10):1762

Non-authorised

1394

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lecithin

Necessary for the metabolism of fat.

Art.13(1) Biotin

Necessary to maintain energy and general vitality

Art.13(1) Vitamin A

Necessary to maintain energy and general vitality

Art.13(1) Vitamin B1

Necessary to maintain energy and general vitality

Art.13(1) Vitamin B12

Necessary to maintain energy and general vitality

Non-compliance with the Regulation contribution to normal because on the basis of the scientific fat metabolism evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation "energy and vitality" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation "energy and vitality" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation "energy and vitality" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation "energy and vitality" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1741

Non-authorised

1597

2010;8(10):1738

Non-authorised

122

2010;8(10):1738

Non-authorised

18

2010;8(10):1738

Non-authorised

26

2010;8(10):1738

Non-authorised

105

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B5

Art.13(1) Vitamin C

Art.13(1) Vitamin E

Art.13(1) Niacin (nicotinic acid)

Necessary to maintain Non-compliance with the Regulation "energy and vitality" energy and general because on the basis of the scientific vitality evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Necessary to maintain Non-compliance with the Regulation "energy and vitality" energy and general because on the basis of the scientific vitality evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Necessary to maintain Non-compliance with the Regulation "energy and vitality" energy and general because on the basis of the scientific vitality evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Niacin (nicotinic acid) Non-compliance with the Regulation Maintenance of normal may help to control because on the basis of the scientific LDL-cholesterol, HDL blood lipid evidence assessed, the proposed cholesterol and profiles/cholesterol/ conditions of use would encourage triglyceride triglycerides excess consumption of this food, concentrations which is contrary to the criteria laid down in the Regulation.

2010;8(10):1738

Non-authorised

62

2010;8(10):1738

Non-authorised

145

2010;8(10):1738

Non-authorised

165

2009;7(9):1224

Non-authorised 46 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Quercus pedunculata-Buds Normal immune system Non-compliance with the Regulation contribution to body -Oak function. because on the basis of the scientific defences against evidence assessed, this claimed effect external agents for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lactobacillus rhamnosus Normalizes the bacterial Non-compliance with the Regulation Digestive health LB21 NCIMB 40564 flora in the intestine because on the basis of the scientific Balances and evidence assessed, this claimed effect strengthen the bacterial for this food has not been flora in the intestine substantiated. Supports a healthy intestinal flora (Helps to) strengthen the natural defences Support gastrointestinal conditions during antibiotic treatment Art.13(1) Lactobacillus plantarum Normalizes the bacterial Non-compliance with the Regulation not validated LB3e DSM 17852 flora in the intestine because on the basis of the scientific Balances and evidence assessed, this food is not strengthen the bacterial sufficiently characterised for a flora in the intestine scientific assessment of this claimed Supports a healthy effect and the claim could not therefore intestinal flora be substantiated. (Helps to) strengthen the natural defences

2010;8(10):1799

Non-authorised

4472

2010;8(2):1487

Non-authorised 1064 (expiry of transitional period 02/01/2014)

2009;7(9):1247

Non-authorised

1066

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum LB7c DSM 17853

Art.13(1) Lactococcus lactis L1A NCIMB 40157

Art.13(1) Lactobacillus rhamnosus LB21 NCIMB 40564

Normalizes the bacterial Non-compliance with the Regulation not validated 2009;7(9):1247 flora in the intestine because on the basis of the scientific Balances and evidence assessed, this food is not strengthen the bacterial sufficiently characterised for a flora in the intestine scientific assessment of this claimed Supports a healthy effect and the claim could not therefore intestinal flora be substantiated. (Helps to) strengthen the natural defences Normalizes the bacterial Non-compliance with the Regulation not validated 2009;7(9):1247 flora in the intestine because on the basis of the scientific Supports a healthy evidence assessed, this food is not intestinal flora sufficiently characterised for a Balances an scientific assessment of this claimed effect and the claim could not therefore be substantiated. Normalizes the bacterial Non-compliance with the Regulation Decreasing potentially 2010;8(2):1487 flora in the intestine. because on the basis of the scientific pathogenic intestinal Balances and evidence assessed, this claimed effect microorganisms strengthen the bacterial for this food has not been flora in the intestine. substantiated. Supports a healthy intestinal flora (Helps to) strengthen the natural defences. Support gastrointestinal conditions during antibiotic treatment.

Non-authorised

1065

Non-authorised

1062

Non-authorised

1064

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus rhamnosus LB21 NCIMB 40564

Art.13(1) Streptococcus oralis NCIMB 40875

Art.13(1) Streptococcus oralis NCIMB 40876

Normalizes the bacterial Non-compliance with the Regulation Reduction of mutans 2010;8(2):1487 flora in the intestine. because on the basis of the scientific streptococci in the oral Balances and evidence assessed, this claimed effect cavity strengthen the bacterial for this food has not been flora in the intestine. substantiated. Supports a healthy intestinal flora (Helps to) strengthen the natural defences. Support gastrointestinal conditions during antibiotic treatment. Normalizing the Non-compliance with the Regulation not validated 2009;7(9):1247 bacterial flora in the because on the basis of the scientific throat and oral cavity evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Normalizing the Non-compliance with the Regulation not validated 2009;7(9):1247 bacterial flora in the because on the basis of the scientific throat and oral cavity evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

1064

Non-authorised

1069

Non-authorised

1070

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Streptococcus sanguis NCIMB 40104

Normalizing the bacterial flora in the throat and oral cavity

Art.13(1) Streptococcus sanguis NCIMB 40873

Normalizing the bacterial flora in the throat and oral cavity

Art.13(1) Omega 6 (Linolenic acid from olive oil)

Nutrient for the skin

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation protection of the skin because on the basis of the scientific from UV-induced evidence assessed, this claimed effect damage for this food has not been substantiated.

2009;7(9):1247

Non-authorised

1067

2009;7(9):1247

Non-authorised

1068

2011;9(6):2235

Non-authorised

3659

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Barley beta-glucan

Art.13(1) Olive Oil

Art.13(1) Olive Oil

Art.13(1) Olive Oil

Odra kiudaine beeta- Non-compliance with the Regulation increase in satiety 2011;9(6):2207 glkaani tarbimine because on the basis of the scientific leading to a reduction in suurendab evidence assessed, this claimed effect energy intake kllastustunnet ehk for this food has not been tiskhutunnet. Odra substantiated. kiudaine beeta-glkaani tarbimine pikendab kllastustunde ehk tiskhutunde silimist. Clarification provided Consuming barley betaglucan increases satiety. Consuming oats beta-glucan prolongs the feeling of satiety. Olive Oil promotes your Non-compliance with the Regulation maintenance of normal 2011;9(4):2044 heart health because on the basis of the scientific (fasting) blood evidence assessed, this claimed effect concentrations of for this food has not been triglycerides substantiated. Olive Oil promotes your Non-compliance with the Regulation maintenance of normal 2011;9(4):2044 heart health because on the basis of the scientific blood HDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Olive Oil promotes your Non-compliance with the Regulation maintenance of normal 2011;9(4):2044 heart health because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

852

Non-authorised

1332

Non-authorised

1332

Non-authorised

1332

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Alpha-linolenic acid (LNA- Omega 3 AlphaOmega 3) linolenic acid helps maintain a healthy blood pressure. Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation maintenance of normal because on the basis of the scientific blood pressure evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food. Omega 3 fatty acids Omega 3 fatty acids Non-compliance with the Regulation maintenance of normal help to maintain a because on the basis of the scientific blood HDL-cholesterol healthy cardiovascular evidence assessed, this claimed effect concentrations system for this food has not been substantiated. Omega Omega 3 fatty acids Non-compliance with the Regulation Maintenance of normal support a healthy heart. because on the basis of the scientific cardiac function evidence assessed, this claimed effect for this food has not been substantiated. EPA and DHA Omega-3 Omega-3 EPA and DHA Non-compliance with the Regulation maintenance of joints fatty acids help maintain healthy because on the basis of the scientific joints evidence assessed, this claimed effect for this food has not been substantiated. EPA and DHA Omega-3 Omega-3 EPA and DHA Non-compliance with the Regulation Enhancement of mood fatty acids support normal because on the basis of the scientific emotional wellbeing evidence assessed, this claimed effect for this food has not been substantiated. Omega-3 fatty acids Omega-3 fatty acids (Hi Non-compliance with the Regulation Maintenance of normal (Hi-EPA) with Glucosamine -EPA) with because on the basis of the scientific joints Glucosamine help to evidence assessed, this claimed effect maintain joint health for this food has not been substantiated.

2009;7(9):1252

Non-authorised

625

2010;8(10):1796

Non-authorised

506

2011;9(4):2050

Non-authorised

509

2009;7(9):1263

Non-authorised

537

2011;9(4):2078

Non-authorised

536

2011;9(6):2247

Non-authorised 1627 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Omega-3 fatty acids/alpha- Omega-3 fatty acids are Non-compliance with the Regulation "Nutrient tasks and 2011;9(4):2050 linoleic acid needed for growth and because on the basis of the scientific interactions" development. evidence assessed, this claimed effect Omega-3 fatty acids are for this food is not sufficiently defined needed as building to be able to be assessed and the material for cells. claim could not therefore be Omega-3 fatty acids substantiated. have an effect on vision. Omega-3 fatty acids have an effect on skin condition. Omega-3 fatty acids have an effect on blood pressure and regulation of nervous system activity. Art.13(1) Omega-3 fatty acids/alpha- Omega-3 fatty acids Non-compliance with the Regulation Maintenance of normal 2011;9(4):2050 linoleic acid have an effect on blood because on the basis of the scientific blood pressure pressure and regulation evidence assessed, this claimed effect of nervous system for this food has not been activity. substantiated. Art.13(1) Omega-3 fatty acids Omega-3 fatty acids Non-compliance with the Regulation protection of the skin 2010;8(10):1796 (EPA/DHA) protect skin from UV because on the basis of the scientific from photo-oxidative damage and keep the evidence assessed, this claimed effect (UV-induced) damage skin healthy for this food has not been substantiated.

Non-authorised

576

Non-authorised

575

Non-authorised

530

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Omega-3 and Omega-6 fatty acids (GLA)

Omega-3 fatty acids with GLA support women during menstruation, PMS and menopause

Non-compliance with the Regulation Womens health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

531

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei LMG P-22043

One of the methods to Non-compliance with the Regulation Reduction of gastropreserve vegetable is to because on the basis of the scientific intestinal discomfort use lactic acid bacteria. evidence assessed, this claimed effect Scientific evidences for this food has not been demonstrate that the substantiated. product (artichoke) contains Lactobacillus paracasei LMG P22043, which is able to reach the intestine alive and in viable form. The consumption of 100 grams portion of product (approx 2 pieces) for not less than following 10 days supports to ensure the presence in the gut of Lactobacillus paracasei LMG P- 22043. Two artichokes carry at least 1 billion of Lactobacillus paracasei LMG P- 22043 live cells. Artichokes are a natural source of fibers, including inuline and FOS, prebiotic substances able to improve the intestinal microflora composition.

2011;9(4):2027

Non-authorised

2964

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

If the strain is ingested as an ingredient for artichokes or other preserved vegetables: - Beneficially affects the intestinal flora; - Supports a healthy intestinal flora; - Modulates bowel activity.

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus paracasei LMG P-22043

One of the methods to Non-compliance with the Regulation decreasing potentially 2011;9(4):2027 preserve vegetable is to because on the basis of the scientific pathogenic gastrouse lactic acid bacteria. evidence assessed, this claimed effect intestinal Scientific evidences for this food has not been microorganisms demonstrate that the substantiated. product (artichoke) contains Lactobacillus paracasei LMG P22043, which is able to reach the intestine alive and in viable form. The consumption of 100 grams portion of product (approx 2 pieces) for not less than following 10 days supports to ensure the presence in the gut of Lactobacillus paracasei LMG P- 22043. Two artichokes carry at least 1 billion of Lactobacillus paracasei LMG P- 22043 live cells. Artichokes are a natural source of fibers, including inuline and FOS, prebiotic substances able to improve the intestinal microflora composition.

Non-authorised

2964

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

If the strain is ingested as an ingredient for artichokes or other preserved vegetables: - Beneficially affects the intestinal flora; - Supports a healthy intestinal flora; - Modulates bowel activity.

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hydroxypropyl methylcellulose (HPMC) Voedingsvezel

Oplosbare vezels zoals Non-compliance with the Regulation increase in satiety 2010;8(10):1739 HPMC helpen because on the basis of the scientific leading to a reduction in gewichtscontrole evidence assessed, this claimed effect energy intake doordat het helpt je for this food has not been langer vol te voelen. substantiated. HPMC helpt gewichtscontrole doordat het helpt je langer vol te voelen. Oplosbare vezels zoals HPMC helpen gewichtscontrole doordat het helpt je langer vol te voelen en het hongergevoel te onderdrukken. HPMC helpt gewichtscontrole doordat het helpt je langer vol te voelen en het hongergevoel te onderdrukken. Oplosbare vezels zoals HPMC helpen het behouden van je gewicht doordat het helpt je langer vol te voelen. HPMC helpt het behouden van je gewicht doordat het helpt je langer vol te voelen. Oplosbare vezels zoals HPMC

Non-authorised

2933

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

helpen het behouden van je gewicht doordat het helpt je langer vol te voelen en het hongergevoel te onderdrukken. HPMC helpt het behouden van je gewicht doordat het helpt je langer vol te voelen 'voelen en het hongergevoel te onderdrukken. Levensmiddelen rijk aan vezels helpen je langer vol te voelen en helpen het behouden van je gewicht.

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Polyunsatu-rated fatty acids: n-3/n-6 (omega 3 / omega 6) ratio;;

Optimal (1/5-1/8) Non-compliance with the Regulation Essential for the 2011;9(6):2228 linolenic / linoleic acid (n because on the basis of the scientific balanced body -3 / n-6) ratio in the diet evidence assessed, this claimed effect functions, with special is essential for the good for this food is not sufficiently defined regards to the immune balanced function of the to be able to be assessed and the system body and the immune claim could not therefore be system.;DHA and EPA substantiated. are formed from these two essential fatty acids. Transformation is mediated by the same enzymes; therefore adequate precursor ratio (n-3 / n-6 = 1/5 1/8) is important for balanced DHA/EPA synthesis.;

Non-authorised

675

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Nutrient, substance, food or food category

Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Polyunsatu-rated fatty acids: n-3/n-6 (omega 3 / omega 6) ratio;;

Optimal (1/5-1/8) Non-compliance with the Regulation Immune system linolenic / linoleic acid (n because on the basis of the scientific -3 / n-6) ratio in the diet evidence assessed, this claimed effect is essential for the good for this food is not sufficiently defined balanced function of the to be able to be assessed and the body and the immune claim could not therefore be system.;DHA and EPA substantiated. are formed from these two essential fatty acids. Transformation is mediated by the same enzymes; therefore adequate precursor ratio (n-3 / n-6 = 1/5 1/8) is important for balanced DHA/EPA synthesis.; Optimises the natural defense system in healthy persons Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

675

Art.13(1) Bovine colostrum

2011;9(4):2048

Non-authorised

1472

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Carbohydrate and protein Optimizes muscle Non-compliance with the Regulation not validated combination glycogen and protein because on the basis of the scientific synthesis and muscle evidence assessed, this food is not recovery. sufficiently characterised for a Helps to rebuild scientific assessment of this claimed muscles after exercise effect and the claim could not therefore (scientifically proven). be substantiated. Prepares for the next workout faster Jumpstart muscle recover. Helps muscles recover their energy - rebuild muscle glycogen, repair muscle protein Art.13(1) Ornithine Ornithine helps to Non-compliance with the Regulation contribution to the normalize hepatic because on the basis of the scientific regulation of the urea function through evidence assessed, this claimed effect cycle regulation of urea cycle. for this food has not been substantiated. Art.13(1) PHGG PHGG contributes to Non-compliance with the Regulation Maintenance of normal lower cholesterol and because on the basis of the scientific blood cholesterol trigyceride levels in the evidence assessed, this claimed effect concentrations blood after the intake of for this food has not been fat-rich foods there by substantiated. improve heart function. Art.13(1) PHGG PHGG contributes to Non-compliance with the Regulation Maintenance of normal lower cholesterol and because on the basis of the scientific blood concentrations of trigyceride levels in the evidence assessed, this claimed effect triglycerides blood after the intake of for this food has not been fat-rich foods there by substantiated. improve heart function.

2011;9(6):2244

Non-authorised

461

2011;9(6):2251

Non-authorised

4270

2010;8(2):1465

Non-authorised

793

2010;8(2):1465

Non-authorised

793

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Partially Hydrolysed Guar PHGG is fermented in Non-compliance with the Regulation changes in short chain 2011;9(6):2254 Gum (PHGG) the gut leading to the because on the basis of the scientific fatty acid (SCFA) production of the evidence assessed, this claimed effect production and/or pH in beneficial SCFA. for this food is not a beneficial the gastro-intestinal PHGG helps promote physiological effect as required by the tract colon health Regulation. PHGG nourishes the digestive tract, where 70% of immune function occurs.

Non-authorised

787

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Partially Hydrolysed Guar PHGG promotes the Non-compliance with the Regulation decreasing potentially 2011;9(6):2254 Gum (PHGG) growth of beneficial because on the basis of the scientific pathogenic gastrointestinal bacteria evidence assessed, this claimed effect intestinal (probiotics) that are for this food has not been microorganisms important for the substantiated. maintenance of the natural digestive balance PHGG supports the natural, beneficial microflora PHGG contributes to proper digestive function by regulating the microflora and short chain fatty acid production. PHGG helps promote healthy intestinal flora to support bowel function PHGG helps maintain digestive balance by promoting good bacteria levels PHGG helps to restore and maintain your natural digestive balance by stimulating the growth of beneficial intestinal flora PHGG acts as a prebiotic to naturally

Non-authorised

788

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PSMIX, miscela di Lactobacillus paracasei I1688 e Lactobacillus salivarius I1794

nourish the beneficial bacteria found in your digestive system PHGG stimulates the development of the intestinal flora PHGG helps to maintain the natural balance of the intestinal flora PHGG has a prebiotic effect Thanks to the prebiotic activity of PHGG, the product has a gentle, effective and progressive action: it helps good development of the intestinal flora PSMIX aiuta a Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, rinforzare le difese because on the basis of the scientific pathogenic gastro2012;10(8):2856 naturali. PSMIX aiuta evidence assessed, this claimed effect intestinal a modulare la risposta for this food has not been microorganisms immunitaria. PSMIX substantiated. riequilibra la risposta immunitaria nei soggetti sensibili a reazioni allergiche. PSMIX coadiuva la risposta immunitaria anche nei casi di infezione virale.

Non-authorised 2972 (expiry of transitional period 02/01/2014)

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PSMIX, miscela di Lactobacillus paracasei I1688 e Lactobacillus salivarius I1794

Art.13(1) PSMIX, miscela di Lactobacillus paracasei I1688 e Lactobacillus salivarius I1794

PSMIX aiuta a Non-compliance with the Regulation Improved lactose rinforzare le difese because on the basis of the scientific digestion naturali. PSMIX aiuta evidence assessed, this claimed effect a modulare la risposta for this food has not been immunitaria. PSMIX substantiated. riequilibra la risposta immunitaria nei soggetti sensibili a reazioni allergiche. PSMIX coadiuva la risposta immunitaria anche nei casi di infezione virale. PSMIX aiuta a Non-compliance with the Regulation Reduction of gastrorinforzare le difese because on the basis of the scientific intestinal discomfort naturali. PSMIX aiuta evidence assessed, this claimed effect a modulare la risposta for this food has not been immunitaria. PSMIX substantiated. riequilibra la risposta immunitaria nei soggetti sensibili a reazioni allergiche. PSMIX coadiuva la risposta immunitaria anche nei casi di infezione virale.

2009;7(9):1247, 2012;10(8):2856

Non-authorised 2972 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2856

Non-authorised 2972 (expiry of transitional period 02/01/2014)

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PSMIX, miscela di Lactobacillus paracasei I1688 e Lactobacillus salivarius I1794

Art.13(1) Pantothenic acid (B-5)

Art.13(1) Phosphatidylcholine

PSMIX favorisce Non-compliance with the Regulation Increasing IL-10 l'equilibrio because on the basis of the scientific production dell'ecosistema evidence assessed, this claimed effect intestinale. PSMIX for this food has not been regola la funzionalit substantiated. intestinale, ripristinando la normale microflora. PSMIX influisce positivamente sul benessere dell'organismo. PSMIX ripristina la naturale microflora dopo trattamento antibiotico/antimicotico. PSMIX utile nella digestione del lattosio. Pantothenic acid Non-compliance with the Regulation adrenal function supports healthy because on the basis of the scientific hormone balance. evidence assessed, this claimed effect Pantothenic acid is for this food is not sufficiently defined required for normal to be able to be assessed and the adrenal function claim could not therefore be substantiated. Participate in the Non-compliance with the Regulation faster recovery from regeneration of the because on the basis of the scientific muscle fatigue after muscular cells. evidence assessed, this claimed effect exercise for this food has not been substantiated.

2009;7(9):1247, 2012;10(8):2856

Non-authorised 2973 (expiry of transitional period 02/01/2014)

2010;8(10):1758

Non-authorised

204

2010;8(10):1741

Non-authorised

4249

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Symbiotic: Probiotics (Lactobacillus helveticus CNCM I-1722, Bifidobacterium bifidum CNCM I-3426, Bifidobacterium infantis CNCM I-3424 ) and fructoligosaccharides from sucrose Art.13(1) Cosse de Haricot

Art.13(1) Maitak

Participates in healthy Non-compliance with the Regulation Contribution to immune microflora balance because on the basis of the scientific defence against essential for body's evidence assessed, this claimed effect pathogens natural defences for this food has not been Stimulates the specific substantiated. and non specific immune system Reinforces the barrier effect against pathogens Participe au confort Non-compliance with the Regulation Increase in renal water urinaire, draineur because on the basis of the scientific elimination naturel Favorise le bon evidence assessed, this claimed effect fonctionnement des for this food is not a beneficial voies urinaires physiological effect as required by the Clarification provided Regulation. Bean husk is depurative and diuretic. Participe au contrle de Non-compliance with the Regulation not validated la glycmie. because on the basis of the scientific Aide matriser le taux evidence assessed, this food is not de sucre. sufficiently characterised for a Contribue la scientific assessment of this claimed rgularisation de la effect and the claim could not therefore glycmie. be substantiated. Clarification provided Helps improve glycemic control / helps maintain normal blood sugar level.

2010;8(2):1470, 2012;10(8):2852

Non-authorised 3016 (expiry of transitional period 02/01/2014)

2010;8(10):1742

Non-authorised

2531

2011;9(6):2244

Non-authorised

2556

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bicarbonate

Pendant les repas, elle Non-compliance with the Regulation Digestive function (NB : l'eau minrale because on the basis of the scientific naturelle DIDIER) evidence assessed, this claimed effect facilite la digestion for this food is not sufficiently defined grce sa teneur en to be able to be assessed and the bicarbonate - Le claim could not therefore be bicarbonate permet une substantiated. meilleure digestion et aide lutter contre les maux d'estomac Art.13(1) Whole grain foods People who eat more Non-compliance with the Regulation not validated whole grain foods tend because on the basis of the scientific to have a healthier body evidence assessed, this food is not weight and gain less sufficiently characterised for a weight over time (as scientific assessment of this claimed part of a low fat diet & effect and the claim could not therefore healthy lifestyle). be substantiated. Art.13(1) Peptides (isoleucine-prolinePeptides help to control Non-compliance with the Regulation Maintenance of normal -proline, IPP + valineblood pressure / because on the basis of the scientific blood pressure proline-proline, VPP) Bioactive peptides help evidence assessed, this claimed effect to control blood for this food has not been pressure. substantiated. Peptides help to control blood pressure and reduce arterial stiffness / Bioactive peptides help to control blood pressure and help to reduce arterial stiffness.

2011;9(6):2228

Non-authorised

377

2010;8(10):1766

Non-authorised

1126

2009;7(9):1259, 2012;10(6):2715

Non-authorised 1832 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Peptides (isoleucine-prolinePeptides help to control Non-compliance with the Regulation maintenance of the 2009;7(9):1259 -proline, IPP + valineblood pressure / because on the basis of the scientific elastic properties of the proline-proline, VPP) Bioactive peptides help evidence assessed, this claimed effect arteries to control blood for this food has not been pressure. Peptides help substantiated. to control blood pressure and reduce arterial stiffness. / Bioactive peptides help to control blood pressure and help to reduce arterial stiffness. Helps to control blood pressure. Helps to improve arterial elasticity / Reduces arterial stiffness. Has a positive effect on arterial function. Art.13(1) magnsium Permet l'organisme deNon-compliance with the Regulation Resistance to mental 2010;8(10):1807 s'adapter au stress because on the basis of the scientific stress evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1832

Non-authorised

381

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sodium phosphate

Art.13(1) Sodium phosphate

Phosphate supplementation increases maximum oxygen uptake in endurance athletes Phosphate supplementation aids aerobic performance in endurance athletes Phosphate supplementation increases oxygen transport in endurance athletes Phosphate supplementation increases maximum oxygen uptake in endurance athletes Phosphate supplementation aids aerobic performance in endurance athletes Phosphate supplementation increases oxygen transport in endurance athletes

Non-compliance with the Regulation increase in endurance 2011;9(6):2263 because on the basis of the scientific capacity evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

318

Non-compliance with the Regulation increase in endurance 2011;9(6):2263 because on the basis of the scientific performance evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

318

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sodium phosphate

Phosphate supplementation increases maximum oxygen uptake in endurance athletes Phosphate supplementation aids aerobic performance in endurance athletes Phosphate supplementation increases oxygen transport in endurance athletes Phosphate supplementation improves endurance performance in endurance athletes Phosphate supplementation delays fatigue during intense exercise Phosphate supplementation helps maintain endurance performance in endurance athletes Phosphate supplementation delays time to exhaustion in endurance athletes

Non-compliance with the Regulation increase in endurance 2011;9(6):2263 because on the basis of the scientific capacity evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

2887

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sodium phosphate

Phosphate supplementation increases maximum oxygen uptake in endurance athletes Phosphate supplementation aids aerobic performance in endurance athletes Phosphate supplementation increases oxygen transport in endurance athletes Phosphate supplementation improves endurance performance in endurance athletes Phosphate supplementation delays fatigue during intense exercise Phosphate supplementation helps maintain endurance performance in endurance athletes Phosphate supplementation delays time to exhaustion in endurance athletes

Non-compliance with the Regulation increase in endurance 2011;9(6):2263 because on the basis of the scientific performance evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

2887

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Mung bean (Vigna Radiata)Phytoestrogens are Non-compliance with the Regulation reduction of 2011;9(6):2248 commonly used by because on the basis of the scientific menopausal discomfort women who cannot / do evidence assessed, this claimed effect not want to use HRT for this food has not been during menopause. PB substantiated. is a source of phytoestrogens. PB is a source of oestrogenic support during menopause and beyond. Oestrogenic support during menopause years and beyond which helps maintain wellbeing and quality of life. Art.13(1) Lignans Phytonutrients that Non-compliance with the Regulation reduction of 2011;9(6):2248 show similar attributes because on the basis of the scientific menopausal discomfort to phytoestrogens in evidence assessed, this claimed effect soya. for this food has not been substantiated.

Non-authorised

1933, 2095

Non-authorised

3129

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Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pine nut oil

Art.13(1) Pitanga

Pine nut oil promotes Non-compliance with the Regulation increase in satiety 2011;9(4):2046 the feeling of satiety.; because on the basis of the scientific leading to a reduction in Pine nut oil gives you evidence assessed, this claimed effect energy intake control on your for this food has not been appetite.; Pine nut oil substantiated. can control your food intake.; Pine nut oil can reduce prospective food intake.; Pine nut oil can prevent snacking.;Pine nut oil is an effective appetite suppressant. Pitanga is a major Non-compliance with the Regulation protection of DNA, 2011;9(4):2021 dietary source of because on the basis of the scientific proteins and lipids from antioxidants evidence assessed, this claimed effect oxidative damage Antioxidants from for this food has not been dietary sources substantiated. contribute to the protection against free radicals which cause cell damage contributes to the protection of cells and tissues from oxidative damage help strengthen our body's natural defences against oxidative stress

Non-authorised

551

Non-authorised

1262

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pitanga

Art.13(1) Pitanga

Art.13(1) Pitanga

Pitanga is a major Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 dietary source of because on the basis of the scientific proteins and lipids from antioxidants/ evidence assessed, this claimed effect oxidative damage Antioxidants from for this food has not been dietary sources substantiated. contribute to the protection against free radicals which cause cell oxidation/ Contributes to the protection of cells and tissues from oxidation/ Help strengthen our body's natural defences against oxidative stress Pitanga is a major Non-compliance with the Regulation protection of the skin 2011;9(4):2021 dietary source of beta- because on the basis of the scientific from UV-induced carotene evidence assessed, this claimed effect (including photobeta-carotene from for this food has not been oxidative) damage dietary sources helps to substantiated. maintain a healthy skin Pitanga is a major Non-compliance with the Regulation protection of the skin 2011;9(4):2021 dietary source of beta- because on the basis of the scientific from UV-induced carotene / betaevidence assessed, this claimed effect (including photocarotene from dietary for this food has not been oxidative) damage sources helps to substantiated. maintain a healthy skin

Non-authorised

2321

Non-authorised

1263

Non-authorised

2320

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Silica / Silicious earth

Art.13(1) Silica / Silicious earth

Plays an important part Non-compliance with the Regulation maintenance of normal 2011;9(6):2259 in the connective tissue/ because on the basis of the scientific bone helps maintain healthy evidence assessed, this claimed effect hair, skin and nails/ for this food has not been helps strengthen skin, substantiated. hair and nails/ helps maintain healthy skin, joints and bone and strong hair and nails/ traditionally used to contribute to the condition Plays an important part Non-compliance with the Regulation contribution to normal 2011;9(6):2259 in the connective tissue/ because on the basis of the scientific formation of collagen helps maintain healthy evidence assessed, this claimed effect and connective tissue hair, skin and nails/ for this food has not been helps strengthen skin, substantiated. hair and nails/ helps maintain healthy skin, joints and bone and strong hair and nails/ traditionally used to contribute to the condition

Non-authorised

1652

Non-authorised

1652

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Silica / Silicious earth

Art.13(1) Silica / Silicious earth

Plays an important part Non-compliance with the Regulation contribution to normal 2011;9(6):2259 in the connective tissue/ because on the basis of the scientific formation of hair and helps maintain healthy evidence assessed, this claimed effect nails hair, skin and nails/ for this food has not been helps strengthen skin, substantiated. hair and nails/ helps maintain healthy skin, joints and bone and strong hair and nails/ traditionally used to contribute to the condition Plays an important part Non-compliance with the Regulation maintenance of normal 2011;9(6):2259 in the connective tissue/ because on the basis of the scientific joints helps maintain healthy evidence assessed, this claimed effect hair, skin and nails/ for this food has not been helps strengthen skin, substantiated. hair and nails/ helps maintain healthy skin, joints and bone and strong hair and nails/ traditionally used to contribute to the condition

Non-authorised

1652

Non-authorised

1652

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Policosanol / Blend of aliphatic alcohols consisting primarily of 1Octacosanol, 1Triacontanol, 1Tetracosanol and 1Hexacosanol - from sugar cane (Saccharum officinarum). Art.13(1) Policosanol / Blend of aliphatic alcohols consisting primarily of 1Octacosanol, 1Triacontanol, 1Tetracosanol and 1Hexacosanol - from sugar cane (Saccharum officinarum).

Policosanol helps to Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 maintain healthy because on the basis of the scientific blood HDL-cholesterol cholesterol levels / evidence assessed, this claimed effect concentrations contributes to good LDL for this food has not been cholesterol level / substantiated. contributes to good HDL cholesterol level

Non-authorised

1747

Policosanol helps to Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 maintain healthy because on the basis of the scientific blood LDL-cholesterol cholesterol levels / evidence assessed, this claimed effect concentrations contributes to good LDL for this food has not been cholesterol level / substantiated. contributes to good HDL cholesterol level

Non-authorised

1747

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Polyphenols from olive Polyphenols are Non-compliance with the Regulation Maintenance of normal 012;10(8):2848, (olive fruit, olive mild waste absorbed from olive oil because on the basis of the scientific blood HDL-cholesterol 2011;9(4):2033 waters or olive oil) in the intestine and evidence assessed, the evidence concentrations metabolized there or in provided is insufficient to substantiate the liver, and have been this claimed effect for this food. shown to be able to bind LDL in vivo. They have demonstrated scavenging properties in vitro that ensure olive oil stability and explain their ability to protect LDL against oxidation. Contributes to good HDL cholesterol level. Polyphenols from olive have an antioxidant activity that may help protect LDL cholesterol and lipid oxidation Art.13(1) Polyphenols Polyphenols are Non-compliance with the Regulation protection of lipids from 2010;8(10):1792 antioxidants, which because on the basis of the scientific oxidative damage naturally occure in evidence assessed, this claimed effect cocoa and therfore in for this food has not been dark chocolate. They substantiated. help to protect our body cells against free radicals.

Non-authorised 1639 (expiry of transitional period 02/01/2014)

Non-authorised

652, 3143

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) polyphenols from French maritime pine bark

Polyphenols from French maritime pine bark ensure antioxidant action. Polyphenols from French maritime pine bark ensure protective effect of the organism Art.13(1) Polyphenols from red wine Polyphenols from red wine: - ensure antioxidant action; - have an antioxidant effect; - help prevent tissue oxidation; - help mop up free radicals in cells; - helps guard against oxidation caused by free radicals Art.13(1) Pomegranate juice Pomegranate juice: plays an important antioxidative function; supports the cardiovascular system. Art.13(1) Folic Acid Positive affect for protection of the lens

Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 because on the basis of the scientific content, and antioxidant evidence assessed, this claimed effect properties for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

1969

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2082

Non-authorised

1640

Non-compliance with the Regulation protection of lipids from 2010;8(10):1750 because on the basis of the scientific oxidative damage evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation maintenance of normal 2010;8(10):1760 because on the basis of the scientific vision evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1201

Non-authorised

87

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin B6

Positive impact on the mood especially in women.

Art.13(1) Soy Isoflavones

Non-compliance with the Regulation Mental performance 2009;7(9):1225 because on the basis of the scientific evidence assessed, the proposed conditions of use would encourage excess consumption of this food, which is contrary to the criteria laid down in the Regulation. Possono aiutare i Non-compliance with the Regulation Maintenance of normal 2011;9(7):2264 capelli della donna in un because on the basis of the scientific skin tonicity periodo di naturale evidence assessed, this claimed effect cambiamento come il has not been linked to a function of the climaterio e la body, as required by Article 13 of the menopausa. Utili per la Regulation. tonicit della pelle. Per il benessere della donna in et menopausale. . Pu aiutare a mantenere i fisiologici livelli di colesterolo. Clarification provided Soy Isoflavones are phytoestrogens that may improve skin tonicity and decrease hair loss during menopause.Soy Isoflavones decreases blood cholesterol levels.

Non-authorised 185 (expiry of transitional period 02/01/2014)

Non-authorised 1704 (expiry of transitional period 02/01/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soy Isoflavones

Possono aiutare i Non-compliance with the Regulation Reduction of vasomotor 2011;9(7):2264, capelli della donna in un because on the basis of the scientific symptoms associated 2012;10(8):2847 periodo di naturale evidence assessed, the evidence with menopause cambiamento come il provided is insufficient to substantiate climaterio e la this claimed effect for this food. menopausa. Utili per la tonicit della pelle. Per il benessere della donna in et menopausale. . Pu aiutare a mantenere i fisiologici livelli di colesterolo. Clarification provided Soy Isoflavones are phytoestrogens that may improve skin tonicity and decrease hair loss during menopause.Soy Isoflavones decreases blood cholesterol levels.

Non-authorised 1704 (expiry of transitional period 02/01/2014)

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soy Isoflavones

Possono aiutare i Non-compliance with the Regulation Contribution to normal 2011;9(7):2264 capelli della donna in un because on the basis of the scientific hair growth periodo di naturale evidence assessed, this claimed effect cambiamento come il for this food has not been climaterio e la substantiated. menopausa. Utili per la tonicit della pelle. Per il benessere della donna in et menopausale. . Pu aiutare a mantenere i fisiologici livelli di colesterolo. Clarification provided Soy Isoflavones are phytoestrogens that may improve skin tonicity and decrease hair loss during menopause.Soy Isoflavones decreases blood cholesterol levels.

Non-authorised

1704

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soy Isoflavones

Art.13(1) L-arginine hydrochloride

Possono aiutare i Non-compliance with the Regulation Maintenance of normal 2011;9(7):2264 capelli della donna in un because on the basis of the scientific blood LDL-cholesterol periodo di naturale evidence assessed, this claimed effect concentrations cambiamento come il for this food has not been climaterio e la substantiated. menopausa. Utili per la tonicit della pelle. Per il benessere della donna in et menopausale. . Pu aiutare a mantenere i fisiologici livelli di colesterolo. Clarification provided Soy Isoflavones are phytoestrogens that may improve skin tonicity and decrease hair loss during menopause.Soy Isoflavones decreases blood cholesterol levels. Power for muscles. Non-compliance with the Regulation Physical performance 2011;9(4):2051 Increases nitric oxide because on the basis of the scientific and condition production. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

1704

Non-authorised

1820

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Xylo-oligosaccharides

Prebiotic; Non-compliance with the Regulation Increasing numbers of 2011;9(6):2228 Stimulate a healthy because on the basis of the scientific gastro-intestinal intestinal flora; evidence assessed, this claimed effect microorganisms Stimulates the growth of for this food is not a beneficial bifidobacteria. physiological effect as required by the Regulation. Art.13(1) Prebiotics Prebiotics/[name of Non-compliance with the Regulation not validated 2011;9(6):2244 specific prebiotic] because on the basis of the scientific - beneficially affects the evidence assessed, this food is not intestinal flora. sufficiently characterised for a - stimulates growth of scientific assessment of this claimed the good/ beneficial gut effect and the claim could not therefore flora. be substantiated. -positively affects the intestinal health Art.13(1) Gamma-linolenic acid Precursor of Non-compliance with the Regulation Reduction of menstrual 2011;9(4):2059 (GLA; C18: 3n-6/C18: 3?-6)prostaglandins and because on the basis of the scientific discomfort provided by evening leukotrienes evidence assessed, this claimed effect primrose oil and/or borage (eicosanoids), hormone- for this food has not been (starflower) oil. like regulators substantiated. associated with many metabolic functions. Ensures adequate intake of PUFA that helps maintain a healthy attitude and temperament during the menstrual cycle.

Non-authorised

782

Non-authorised

3092

Non-authorised

495

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Echium oil

Precursor of Non-compliance with the Regulation Reduction of 2011;9(4):2061 prostaglandins which because on the basis of the scientific inflammation are associated with evidence assessed, this claimed effect many of the body's for this food is not a beneficial metabolic functions physiological effect as required by the (immune system, Regulation. reduction of inflammation). Art.13(1) Pollen pistil extract + SOD Prevents the formation Non-compliance with the Regulation reduction of muscle 2010;8(10):1753 of lactic acid in muscles. because on the basis of the scientific fatigue during exercise Prevents the muscles evidence assessed, this claimed effect from tiring during for this food has not been exertion. substantiated. Reduces lactic acid production in muscles. Art.13(1) Lactic acid bacterium Probiootiline Non-compliance with the Regulation decreasing potentially 2011;9(4):2025 Lactobacillus fermentum piimhappebakter because on the basis of the scientific pathogenic gastroME-3 Lactobacillus evidence assessed, this claimed effect intestinal fermentum ME-3 aitab for this food has not been microorganisms tsta/suurendab substantiated. organismi kaitsevimet. ME-3 toetab seedimist, suurendades kasulike laktobatsillide ldhulka soolestikus, mis kindlustavad toitainete lhustamist kergemini omastatavateks henditeks.

Non-authorised

547

Non-authorised

1840

Non-authorised

3025

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Optibiotics containing Probiotic Bacillus mesentericus TOA, Promotes healthy Clostridium butyricum TO-Aintestinal flora and Streptococcus faecalis T-110 Beneficially affects the intestinal flora Supports a healthy intestinal flora; Balances the intestinal flora. Synergistic Probiotic formula

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

943

Art.13(1) Lactobacillus acidophilus NCFM ATCC SD5221

Contains probiotics Probiotic - helps to Non-compliance with the Regulation Increasing numbers of 2011;9(4):2061 strengthen your body's because on the basis of the scientific gastro-intestinal natural defences; helps evidence assessed, this claimed effect microorganisms to strengthen the for this food is not a beneficial natural defenses; helps physiological effect as required by the to strengthen the Regulation. natural defences of your body; contributes to enhance your body's resistance.

Non-authorised

884

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum 299v

Non-compliance with the Regulation reduction of flatulence 2011;9(4):2037 because on the basis of the scientific and bloating evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Lactobacillus acidophilus, Probiotics (Lactobacillus Non-compliance with the Regulation not validated 2010;8(2):1470 Bifidobacterium infantis, acidophilus, because on the basis of the scientific Bifidobacterium bifidum Bifidobacterium infantis, evidence assessed, this food is not Bifidobacterium bifidum) sufficiently characterised for a help maintain proper scientific assessment of this claimed functioning of digestive effect and the claim could not therefore tract be substantiated. help to regulate intestinal function Art.13(1) Lactobacillus acidophilus, Probiotics (Lactobacillus Non-compliance with the Regulation not validated Bifidobacterium infantis, acidophilus, because on the basis of the scientific Bifidobacterium bifidum Bifidobacterium infantis, evidence assessed, this food is not Bifidobacterium bifidum) sufficiently characterised for a help to maintain scientific assessment of this claimed property functioning of effect and the claim could not therefore immune system be substantiated. Art.13(1) Lactobacillus acidophilus, Probiotics (Lactobacillus Non-compliance with the Regulation not validated Bifidobacterium infantis, acidophilus, because on the basis of the scientific Bifidobacterium bifidum Bifidobacterium infantis, evidence assessed, this food is not Bifidobacterium bifidum) sufficiently characterised for a help to scientific assessment of this claimed maintain/replenish the effect and the claim could not therefore natural bacterial flora of be substantiated. the digestive tract

Probiotic - reduces flatulences/ bloating

Non-authorised

902

Non-authorised

3028

2010;8(2):1470

Non-authorised

3030

2010;8(2):1470

Non-authorised

3029

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Claim

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Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium lactis B420 Probiotics; '-helps to Non-compliance with the Regulation decreasing potentially 2010;8(10):1767 improve the level of because on the basis of the scientific pathogenic gastronatural good bacteria in evidence assessed, this claimed effect intestinal your body; -maintains for this food has not been microorganisms the balance of healthy substantiated. microflora; -beneficially affects the intestinal flora; Art.13(1) Bifidobacterium lactis B420 Probiotics; '-helps to Non-compliance with the Regulation increasing numbers of 2010;8(10):1767 improve the level of because on the basis of the scientific gastro-intestinal natural good bacteria in evidence assessed, this claimed effect microorganisms your body; -maintains for this food is not a beneficial the balance of healthy physiological effect as required by the microflora; -beneficially Regulation. affects the intestinal flora; Art.13(1) Lactobacillus acidophilus Probiotics; -helps to Non-compliance with the Regulation not validated 2009;7(9):1247 (ATCC SD5221) & strenghten your body's because on the basis of the scientific Bifidobacterium lactis natural defences; evidence assessed, this food is not ATCC SD5220 -helps to strengthen the sufficiently characterised for a natural defenses of scientific assessment of this claimed children; effect and the claim could not therefore -contributes to enhance be substantiated. your body's resistance to cold & flu; -contributes to enhance children 's resistance to cold & flu;

Non-authorised

864

Non-authorised

864

Non-authorised

869

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EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glatine

Art.13(1) Honey

Promote keratin formation. Strength hair. Hair is more resistant and thick. Increase hair resistance. Promotes a good heart functioning and a balanced level of blood lipids.

Non-compliance with the Regulation Maintenance of normal 2011;9(6):2228 because on the basis of the scientific structure and evidence assessed, this claimed effect appearance of hair and has not been linked to a function of the nails body, as required by Article 13 of the Regulation. 2011;9(6):2243

Non-authorised 4202 (expiry of transitional period 02/01/2014)

Art.13(1) Royal jelly

Art.13(1) Chromium

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Promotes a good heart Non-compliance with the Regulation not validated functioning and a because on the basis of the scientific balanced level of the evidence assessed, this food is not blood lipids sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Promotes Non-compliance with the Regulation contribution to the carbohydrates because on the basis of the scientific maintenance or catabolism, helping in evidence assessed, the evidence achievement of a body weight provided is insufficient to substantiate normal body weight maintaining. this claimed effect for this food.

Non-authorised

4678

2011;9(4):2083

Non-authorised

4696, 4697

2010;8(10):1732

Non-authorised

4665

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Protease, lipase and other Promotes digestion The Non-compliance with the Regulation Improvement of the 2011;9(6):2228 enzymes that break down preparations enzymes because on the basis of the scientific digestion of carbohydrates break down proteins. A evidence assessed, this claimed effect macronutrients (e.g. food supplement for this food is not a beneficial carbohydrates, proteins containing protease physiological effect as required by the and lipids) enzymes is particularly Regulation. recommended after heavy meals and, as the years pass, to complement the weakening secretion of enzymes that break down proteins. Art.13(1) Guar gum partially Promotes good Non-compliance with the Regulation changes in bowel 2011;9(6):2254 hydrolyzed intestinal health. because on the basis of the scientific function Improves bowel function evidence assessed, this claimed effect and gut comfort. for this food has not been substantiated. Art.13(1) Guar gum partially Promotes good Non-compliance with the Regulation reduction of gastro2011;9(6):2254 hydrolyzed intestinal health. because on the basis of the scientific intestinal discomfort Improves bowel function evidence assessed, this claimed effect and gut comfort. for this food has not been substantiated. Art.13(1) Guar gum partially Promotes good Non-compliance with the Regulation changes in short chain 2011;9(6):2254 hydrolyzed intestinal health. because on the basis of the scientific fatty acid (SCFA) Improves bowel function evidence assessed, this claimed effect production and/or pH in and gut comfort. for this food is not a beneficial the gastro-intestinal physiological effect as required by the tract Regulation.

Non-authorised

1842

Non-authorised

813

Non-authorised

813

Non-authorised

813

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wholegrain

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus acidophilus, Promotes gut activity Non-compliance with the Regulation not validated Lactobacillus paracasei , because on the basis of the scientific Lactobacillus rhamnosus Gut-friendly evidence assessed, this food is not and Bifidobacterium lactis sufficiently characterised for a lactic acid bacteria Normalises gut activity scientific assessment of this claimed effect and the claim could not therefore Balances gut activity be substantiated. Maintains stomach and gut well-being For gut well-being Normalises the guts bacteria balance Balances the guts bacteria population For the protection of a healthy b

Promotes gut activity

2010;8(10):1766

Non-authorised

831

2009;7(9):1247

Non-authorised

1055

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Flaxseed oil/alpha-linoleic Promotes heart health Non-compliance with the Regulation Maintenance of normal acid because on the basis of the scientific cardiac function evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Shark cartilage Promotes joint Non-compliance with the Regulation maintenance of joints functioning. The because on the basis of the scientific glucosaminoglycans evidence assessed, this claimed effect contained in shark for this food has not been cartilage are the substantiated. building blocks of human cartilage, joint tissue and joint surfaces. Glucosaminoglycan levels change with age and with strong wear. Use of shark cartilage powder restores joint functioning. Art.13(1) Chromium Promotes lipid Non-compliance with the Regulation contribution to the catabolism, helping in because on the basis of the scientific maintenance or body weight evidence assessed, the evidence achievement of a maintaining. provided is insufficient to substantiate normal body weight this claimed effect for this food. Art.13(1) Vitamin C Promotes lutein / Non-compliance with the Regulation antioxidant function of zeaxanthin function because on the basis of the scientific lutein evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(4):2050

Non-authorised

579

2009;7(9):1269

Non-authorised

1853

2010;8(10):1732

Non-authorised

4666

2009;7(9):1226

Non-authorised

146

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chromium

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Promotes metabolism. Non-compliance with the Regulation contribution to the 2010;8(10):1732 Supports weight control because on the basis of the scientific maintenance or physiologically. evidence assessed, the evidence achievement of a provided is insufficient to substantiate normal body weight this claimed effect for this food. Lactobacillus reuteri lactic Promotes mouth and Non-compliance with the Regulation not validated 2009;7(9):1247 acid bacteria tooth health because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Herbal yeast plasmolycate Promotes the Non-compliance with the Regulation Absorption of 2011;9(6):2228 (saccharomyces absorption of nutrients. because on the basis of the scientific nutrients cerevisiae) Helps the body utilise evidence assessed, this claimed effect nutrients obtained from for this food is not sufficiently defined food more effectively. to be able to be assessed and the claim could not therefore be substantiated. Rutin Promotes the Non-compliance with the Regulation improvement of 2010;8(10):1751 functioning of blood because on the basis of the scientific endothelium-dependent vessels (arteries, veins, evidence assessed, this claimed effect vasodilation capillaries), normalizes for this food has not been penetrability, health and substantiated. elasticity of the blood vessel walls. Lecithin -/phosphatidyl Promotes the good Non-compliance with the Regulation maintenance of normal 2010;8(10):1741 choline heart functioning and a because on the basis of the scientific blood cholesterol balanced level of blood evidence assessed, this claimed effect concentrations lipids. for this food has not been substantiated.

Non-authorised

339

Non-authorised

1057

Non-authorised

1814

Non-authorised

1783

Non-authorised

4687

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) PROPOLIS

Promotes upper Non-compliance with the Regulation not validated 2010;8(10):1810 respiratory tract health because on the basis of the scientific Contributes to the evidence assessed, this food is not resistance of the sufficiently characterised for a organism scientific assessment of this claimed Supports the natural effect and the claim could not therefore defence mechanism, be substantiated. especially at the level of the upper respiratory tract Pleasant for temporary croakiness For an appropriate and easy respiration Contributes to to the respiratory comfort Soothing for throat and chest (airways). Art.13(1) Long chain Omega 6 Promotes youth and Non-compliance with the Regulation Maintenance of the 2011;9(4):2059 polyunsaturated fatty acid elasticity of the skin / because on the basis of the scientific barrier function of the GLA ( gamma-linolenic Helps to maintain skin evidence assessed, this claimed effect skin acid) hydration / Contributes for this food has not been to women well being substantiated. Art.13(1) Beta-carotene, vitamine C, Protect fatty acids of Non-compliance with the Regulation protection of lipids in 2011;9(6):2246 vitamine E et slnium skin cell membranes because on the basis of the scientific the skin from UVfrom oxidation after sun evidence assessed, this claimed effect induced photo-oxidative exposure for this food has not been damage substantiated.

Non-authorised

1242

Non-authorised

591

Non-authorised

4288

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Polyphenols from processed fruits and tea

Protects the cells; Antioxidant Properties; With Natural Fruit and Tea Antioxidants

Art.13(1) Vitamin C

Art.13(1) Vitamin E

Art.13(1) Sea buckthorn berry oil (cold-pressed)

Non-compliance with the Regulation protection of DNA, because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Protects the eye from Non-compliance with the Regulation maintenance of vision oxidative and photobecause on the basis of the scientific oxidative stress evidence assessed, the evidence Protects the eye provided is insufficient to substantiate Antioxidant vitamin C, is this claimed effect for this food. associated with the health of the retina and lens, which can be damaged over the years by free radical damage e.g. caused by sunlight, smoke & pollution Protects the lens. Non-compliance with the Regulation maintenance of normal because on the basis of the scientific vision by protection of evidence assessed, this claimed effect the lens of the eye for this food has not been substantiated. Protects the liver. Non-compliance with the Regulation Liver health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1752

Non-authorised

1900

2009;7(9):1226

Non-authorised

142

2010;8(10):1816

Non-authorised

167

2011;9(6):2228

Non-authorised

583

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Page 656

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus crispatus P 17631

Art.13(1) Lactobacillus crispatus P 17631

Protegge l'ecosistema Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, intestinale limitando lo because on the basis of the scientific pathogenic gastro2012;10(8):2858 sviluppo di evidence assessed, this claimed effect intestinal microrganismi patogeni. for this food has not been microorganisms Ripristina la naturale substantiated. microflora dopo trattamento antibiotico/antimicotico. Influisce positivamente sul benessere dell'organismo. Protegge l'ecosistema Non-compliance with the Regulation Improved lactose 2009;7(9):1247, intestinale limitando lo because on the basis of the scientific digestion 2012;10(8):2858 sviluppo di evidence assessed, this claimed effect microrganismi patogeni. for this food has not been Ripristina la naturale substantiated. microflora dopo trattamento antibiotico/antimicotico. Influisce positivamente sul benessere dell'organismo.

Non-authorised 1030 (expiry of transitional period 02/01/2014)

Non-authorised 1030 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus crispatus P 17631

Protegge l'ecosistema Non-compliance with the Regulation Reduction of gastro2009;7(9):1247, intestinale limitando lo because on the basis of the scientific intestinal discomfort 2012;10(8):2858 sviluppo di evidence assessed, this claimed effect microrganismi patogeni. for this food has not been Ripristina la naturale substantiated. microflora dopo trattamento antibiotico/antimicotico. Influisce positivamente sul benessere dell'organismo. Art.13(1) Lactobacillus plantarum P Protegge l'ecosistema Non-compliance with the Regulation Decreasing potentially 2009;7(9):1247, 17630 intestinale limitando lo because on the basis of the scientific pathogenic gastro2012;10(8):2858 sviluppo di evidence assessed, this claimed effect intestinal microrganismi patogeni. for this food has not been microorganisms Ripristina la naturale substantiated. microflora dopo trattamento antibiotico/antimicotico. Influisce positivamente sul benessere dell'organismo. E' utile nella digestione del lattosio.

Non-authorised 1030 (expiry of transitional period 02/01/2014)

Non-authorised 2966 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum P Protegge l'ecosistema Non-compliance with the Regulation Improved lactose 17630 intestinale limitando lo because on the basis of the scientific digestion sviluppo di evidence assessed, this claimed effect microrganismi patogeni. for this food has not been Ripristina la naturale substantiated. microflora dopo trattamento antibiotico/antimicotico. Influisce positivamente sul benessere dell'organismo. E' utile nella digestione del lattosio. Art.13(1) Lactobacillus plantarum P Protegge l'ecosistema Non-compliance with the Regulation Reduction of gastro17630 intestinale limitando lo because on the basis of the scientific intestinal discomfort sviluppo di evidence assessed, this claimed effect microrganismi patogeni. for this food has not been Ripristina la naturale substantiated. microflora dopo trattamento antibiotico/antimicotico. Influisce positivamente sul benessere dell'organismo. E' utile nella digestione del lattosio. Art.13(1) Protein Protein supports a Non-compliance with the Regulation contribution to the satiety feeling and helps because on the basis of the scientific maintenance or to control hunger evidence assessed, this claimed effect achievement of a sensations for this food has not been normal body weight substantiated.

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2966 (expiry of transitional period 02/01/2014)

2009;7(9):1247, 2012;10(8):2858

Non-authorised 2966 (expiry of transitional period 02/01/2014)

2010;8(10):1811

Non-authorised

730

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Protein

Protein supports a Non-compliance with the Regulation increase in satiety 2010;8(10):1811 satiety feeling and helps because on the basis of the scientific leading to a reduction in to control hunger evidence assessed, this claimed effect energy intake sensations for this food has not been substantiated.

Non-authorised

730

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) A combination of three probiotic strains: -Lactobacillus gasseri 57C -Lactobacillus fermentum 57A -Lactobacillus plantarum 57B Trade name of the food supplement: prOVag

Provag contributes to re Non-compliance with the Regulation Defence against -balance the because on the basis of the scientific vaginal pathogens physiological bacterial evidence assessed, this claimed effect flora and to maintain a for this food has not been proper vaginal pH. substantiated. Provag shows an antagonistic effect on the most common pathogenic bacteria and fungi in the urogenital system Oral probiotics of a vaginal effect are used during and after taking antibacterial, antitrichomonal and antimycotic antibiotics. Provag contains living lactobacilli, which due to their strong probiotic properties demonstrate a beneficial effect on the urogenital system microflora in women Provag helps to bring back the physiological flora of the urogenital system and maintains a balanced pH in the vagina, which inhibits the growth of pathogenic

2009;7(9):1247, 2012;10(6):2719

Non-authorised 934 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

microorganisms Provag may be used during and after the intake of metronidazole and cotrimoxazole Oral probiotics of a vaginal effect are recommended during the perimenopausal period (climacteric) Oral probiotics of a vaginal effect are recommended to women during and after menstruation Oral probiotics of a vaginal effect are recommended to women before and after the urogenital system surgery Oral probiotics of a vaginal effect are good for women who attend swimming pools, travel frequently, use a jacuzzi or sunbed Provag facilitates reinstating the physiological bacterial flora and a correct

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

vaginal pH and lessens the growth of pathogenic microorganisms Art.13(1) Huile de noisettes : Hazel Provides an essential nut (Corylus avellana) oil fatty acid entering the composition of the scalp. Provides an essential fatty acid entering the composition of the skin. Art.13(1) L-tyrosine Provides energy

Art.13(1) Carbohydrate

Non-compliance with the Regulation Skin health because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation increased attention because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Provides energy. Non-compliance with the Regulation not validated Re-energises during because on the basis of the scientific and post exercise bouts evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised

4241

2011;9(6):2270

Non-authorised

1930

2011;9(6):2244

Non-authorised

458

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium infantis UCC35624

Provides friendly bacteria that play an important role in basic digestion, proper metabolism and overall well-being. Will boost the level of natural good bacteria in your body, which can aid digestion and general well-being

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1093

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Prune Juice

Art.13(1) Prunes (Dried plums)

Prune juice help the Non-compliance with the Regulation maintenance of normal 2010;8(10):1768 maintenance of healthy because on the basis of the scientific bowel function body function. evidence assessed, this claimed effect Prune juice help with for this food has not been the maintenance of substantiated. health in general Prune juice helps maintain bowel regularity which can help to ensure a healthy digestion and bowel. Prune juice is beneficial to the health of the stomach and digestive system. Prune juice is good for healthy bowel function. Prune juice is good for (regular) digestion Prune juice has a natural laxative effect that can contribute to a healthy digestion and bowel. Prunes are a natural Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 source of (good for you) because on the basis of the scientific content, and antioxidant antioxidants Prunes are evidence assessed, this claimed effect properties a (good) source of for this food is not a beneficial antioxidants Prunes are physiological effect as required by the high in antioxidants Regulation.

Non-authorised

1166

Non-authorised

1285

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Purple Grape Juice

Art.13(1) Purple Grape Juice

Art.13(1) Q10 (Coenzyme Q, Ubiquinione)

Purple grape juice Non-compliance with the Regulation Blood flow/vascular 2011;9(6):2228 contributes to healthy because on the basis of the scientific function arteries/ evidence assessed, this claimed effect contributes to a healthy for this food is not sufficiently defined blood flow/ to be able to be assessed and the contributes to healthy claim could not therefore be vascular functions. substantiated. Purple grape juice is a Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 major dietary source of because on the basis of the scientific proteins and lipids from antioxidants/ evidence assessed, this claimed effect oxidative damage Antioxidants from for this food has not been dietary sources substantiated. contribute to the protection against free radicals which cause cell damage/contributes to the protection of cells and tissues from oxidative damage/ help strengthen our body's natural defences against oxidative stress Q10 is a component in Non-compliance with the Regulation contribution to normal 2010;8(10):1793 the formation of energy because on the basis of the scientific energy-yielding Q10 contribute to the evidence assessed, this claimed effect metabolism formation of energy in for this food has not been cells substantiated.

Non-authorised

1265

Non-authorised

1264

Non-authorised

1512

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Melon extract (containing Quenches excess free Non-compliance with the Regulation protection of the skin 2010;8(10):1753 SOD) /Wheat Gliadin radicals such as from because on the basis of the scientific from photo-oxidative pollutants evidence assessed, this claimed effect (UV-induced) damage - The anti-ageing for this food has not been catalyst substantiated. - Fights premature ageing - Fights the signs of premature ageing - The anti-premature ageing catalyst Art.13(1) Quercetin Quercetin containing Non-compliance with the Regulation Protection of DNA, 2011;9(4):2067 foods contribute to keep because on the basis of the scientific proteins and lipids from your body healthy evidence assessed, this claimed effect oxidative damage Antioxidant containing for this food has not been foods support of healthy substantiated. ageing Antioxidants contribute to the total antioxidant capacity of the body and may help strengthen our bodys defences Art.13(1) Resistant starch- type 2 RS promotes a healthy Non-compliance with the Regulation digestive health 2011;9(4):2024 (RS) from high amylose digestive system. because on the basis of the scientific benefits maize RS delivers prebiotic evidence assessed, this claimed effect activities. for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

3161

Non-authorised

1647

Non-authorised

682

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Rapeseed oil

Rapeseed oil helps to control cholesterol

Art.13(1) Glycomacropeptide

Art.13(1) Glycomacropeptide

Non-compliance with the Regulation maintenance of normal 2011;9(4):2068 because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Recognized for hunger Non-compliance with the Regulation contribution to the 2011;9(6):2246 feeling reduction because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated. Recognized for hunger Non-compliance with the Regulation increase in satiety 2011;9(6):2246 feeling reduction because on the basis of the scientific leading to a reduction in evidence assessed, this claimed effect energy intake for this food has not been substantiated.

Non-authorised

580

Non-authorised

4252

Non-authorised

4252

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coquille d'hutre

Recommand lors de problmes lis au cycle menstruel. Soulage les douleurs lies au cycle menstruel. A utiliser en cas de rgles douloureuses. Clarification provided Oyster shells are rich source of calcium that alleviates the premenstrual syndrome/oyster shells are a rich source of calcium that reduces premenstrual pain and premenstrual water retention.

Non-compliance with the Regulation reduction in the severity 2010;8(10):1725 because on the basis of the scientific of symptoms related to evidence assessed, this claimed effect the premenstrual for this food has not been syndrome substantiated.

Non-authorised

348, 1892

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Ananas : Pineapple powderRecommended during Non-compliance with the Regulation contribution to the (Ananas sativus) obtained slimming diet, at the because on the basis of the scientific maintenance or from fruit juice and stems same time of dietary evidence assessed, this claimed effect achievement of a AND Dry measures. for this food has not been normal body weight aqueous extract of Pineapple is a tropical substantiated. pineapple standardized at plant whose stems 2% of bromelain contain bromelain, a proteolytic enzymatic complex. Bromelain is a proteolytic enzyme with anti-edematous activity which can help to drain tissues with cellulitis. Art.13(1) Plante : Pomme Reconnu pour faciliter la Non-compliance with the Regulation changes in bowel Malus communis (=syn. digestion/Reconnu pour because on the basis of the scientific function Pirus malus) (Apple) contribuer un confort evidence assessed, this claimed effect digestif/reconnu pour for this food has not been favoriser le transit par substantiated. un effet de lest Clarification provided Traditionally used to facilitate the digestion / traditionally used to contribute to the digestive comfort / traditionally used to facilitate a good digestion / traditionally used to enhance le digestion by an effect of load

2011;9(6):2246

Non-authorised

3726

2011;9(6):2246

Non-authorised

3516

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Page 670

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Royal jelly

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Reconstituent and tonic Non-compliance with the Regulation "tonic" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Lacprodan PL-20; Milk Reduce mental and Non-compliance with the Regulation not validated protein concentrate with a emotional stress and because on the basis of the scientific high content of enhance memory evidence assessed, this food is not phospholipids. (Effective sufficiently characterised for a component: Phosphatidyl scientific assessment of this claimed serine) effect and the claim could not therefore be substantiated. Probiotic supplement: Reduces stress-induced Non-compliance with the Regulation not validated Lactobact omni FOS immune responses because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. POLICOSANOL Reducing cholesterol Non-compliance with the Regulation maintenance of normal levels because on the basis of the scientific blood HDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. POLICOSANOL Reducing cholesterol Non-compliance with the Regulation maintenance of normal levels because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

2010;8(10):1738

Non-authorised

1703

2010;8(10):1749

Non-authorised

1927

2010;8(2):1470

Non-authorised

2998

2011;9(6):2255

Non-authorised

4693

2011;9(6):2255

Non-authorised

4693

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Page 671

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Decrease of trans fatty acids;

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Reduction of the intake Non-compliance with the Regulation not validated 2011;9(4):2083 of the trans fatty acids because on the basis of the scientific under 1 % of the daily evidence assessed, this food is not energy intake helps to sufficiently characterised for a maintain the normal scientific assessment of this claimed total cholesterol and effect and the claim could not therefore LDL cholesterol levels be substantiated. in blood. Vitamin E Regeneration of vitamin Non-compliance with the Regulation regeneration of the 2010;8(10):1816 C because on the basis of the scientific reduced form of vitamin evidence assessed, this claimed effect C for this food has not been substantiated. Fruits and vegetables Regular consumption of Non-compliance with the Regulation not validated 2011;9(6):2245 fruit and vegetables because on the basis of the scientific support the heart and evidence assessed, this food is not cardiovascular health. sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Magnesium Regulates blood Non-compliance with the Regulation Maintenance of normal 2010;8(10):1807 pressure. because on the basis of the scientific blood pressure evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food. Lactium-peptide compound Regulates stress Non-compliance with the Regulation alleviation of 2011;9(6):2273 hormone secretion. because on the basis of the scientific psychological stress Stabilises vital functions evidence assessed, this claimed effect during stress. for this food has not been substantiated.

Non-authorised

672, 4333

Non-authorised

203

Non-authorised

1301

Non-authorised

344

Non-authorised

1819

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Magnesium

Regulates sugar balance.

Art.13(1) Wheat germ oil

Relieves painful menstruation

Art.13(1) Honey

Reminalizing of the organism

Art.13(1) Foie de chimre

Renforce les dfenses naturelles Soutient le systme de dfense

Art.13(1) Colostrum bovin

Renforce les dfenses naturelles Soutient le systme de dfense Stimule les dfenses naturelles

Non-compliance with the Regulation Maintenance of normal because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated. Non-compliance with the Regulation relief of menstrual pain because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1807

Non-authorised

342

2010;8(10):1762

Non-authorised

1395

2011;9(6):2243

Non-authorised

4679

2010;8(10):1799

Non-authorised

1895

2010;8(10):1799

Non-authorised

1891

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chondroitin Sulphate

Art.13(1) Monounsatu-rated fatty acids (mainly oleic acid)

Art.13(1) Monounsaturated fatty acids (mainly oleic acid)

Renowned for helping Non-compliance with the Regulation maintenance of joints 2009;7(9):1262 maintain joint mobility because on the basis of the scientific and flexibility. evidence assessed, this claimed effect Chondroitin (and for this food has not been glucosamine) may help substantiated. to support healthy knees. Chondroitin (and glucosamine) may help to support healthy joints. Replacement saturated Non-compliance with the Regulation maintenance of normal 2011;9(4):2043 fatty acids by because on the basis of the scientific (fasting) blood monounsaturated fatty evidence assessed, this claimed effect concentrations of acids in the diet is for this food has not been triglycerides beneficial for the blood substantiated. total cholesterol, LDL cholesterol and triglyceride levels. Replacement saturated Non-compliance with the Regulation maintenance of normal 2011;9(4):2043 fatty acids by because on the basis of the scientific (fasting) blood monounsaturated fatty evidence assessed, this claimed effect concentrations of acids in the diet is for this food has not been triglycerides beneficial for the blood substantiated. total cholesterol, LDL cholesterol and triglyceride levels.

Non-authorised

1505

Non-authorised

4334

Non-authorised

673

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Resistant starch

Art.13(1) Wheat germ oil

Resistant starch helps favour a normal colon metabolism; Resistant starch is a butyrogenic fibre, butyrate participates to a normal colonic functions and metabolism Retards the ageing processes

Non-compliance with the Regulation Favours normal colon 2011;9(4):2024 because on the basis of the scientific metabolism evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

783

Art.13(1) Beta-Carotene

Art.13(1) Royal jelly

Non-compliance with the Regulation protection of cells from 2010;8(10):1762 because on the basis of the scientific premature aging evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Revitalizing for hair. Non-compliance with the Regulation maintenance of normal 2010;8(10):1754 Revitalizing for because on the basis of the scientific hair teguments evidence assessed, this claimed effect for this food has not been substantiated. Royal jelly could Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 promote the protection because on the basis of the scientific proteins and lipids from of the cells against evidence assessed, this claimed effect oxidative damage certain harmful effects for this food has not been provoked by free substantiated. radicals.

Non-authorised

1393

Non-authorised

4660

Non-authorised

1229

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Rye flour

Rukkijahu iseloomustab Non-compliance with the Regulation not validated 2011;9(6):2243 madal glkeemiline because on the basis of the scientific indeks. evidence assessed, this food is not Clarification provided sufficiently characterised for a Rye flower is scientific assessment of this claimed characterised by low effect and the claim could not therefore glycaemic index. be substantiated. Art.13(1) Pollen pistil extract + SOD SOD enzyme-rich Non-compliance with the Regulation protection of DNA, 2010;8(10):1753 pollen pistil extract. Due because on the basis of the scientific proteins and lipids from to the SOD it contains, it evidence assessed, this claimed effect oxidative damage also functions as an for this food has not been antioxidant. Gives substantiated. energy. Invigorating Art.13(1) Sea buckthorn oil and Sea buckthorn berry Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 flavonoids extracted from extract contains because on the basis of the scientific content, and antioxidant sea buckthorn berries antioxidants and evidence assessed, this claimed effect properties flavonoids. Flavonoids for this food is not a beneficial may intercept free physiological effect as required by the radicals. Regulation.

Non-authorised

1266

Non-authorised

1839

Non-authorised

1850

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sea buckthorn seed oil and Sea buckthorn seed pulp oil and pulp oil nourish the mucous membranes and help to maintain their normal structure and functioning. Sea buckthorn seed and pulp oil moisturise dry mucous membranes. Sea buckthorn seed and pulp oil strengthen and protect the mucous membranes of the stomach. Art.13(1) Selen Selen ist wichtig fr die Gelenkfunktion Clarification provided selenium is important for joint function Art.13(1) Selenium Selenium is necessary for normal cardiovascular function.

Non-compliance with the Regulation Mucous membranes 2011;9(6):2228 because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

589

Art.13(1) Selenium

Non-compliance with the Regulation maintenance of normal 2010;8(10):1727 because on the basis of the scientific joints evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation function of the heart 2009;7(9):1220 because on the basis of the scientific and blood vessels evidence assessed, the evidence provided is insufficient to substantiate this claimed effect for this food. Selenium supports Non-compliance with the Regulation cognitive function 2009;7(9):1220 better brain functioning because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

409

Non-authorised

280

Non-authorised

285

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sialic acid

Sialic acid may improve Non-compliance with the Regulation learning and memory learning and memory because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Silicon (as stabilized Silicon helps protect the Non-compliance with the Regulation protection against 0ligomeric orthosilicic acid brain; Silicon reduces because on the basis of the scientific aluminium (OSA) aluminium accumulation evidence assessed, this claimed effect accumulation in the in the brain for this food has not been brain substantiated. Art.13(1) Silicon (as stabilized Silicon helps stimulate Non-compliance with the Regulation stimulating 0ligomeric orthosilicic acid macrophages and because on the basis of the scientific macrophages and (OSA) increases circulating evidence assessed, this claimed effect increasing circulating lymphocytes for this food has not been lymphocytes substantiated. Art.13(1) Silicon (as stabilized Silicon is beneficial for Non-compliance with the Regulation cardiovascular health 0ligomeric orthosilicic acid cardiovascular health; because on the basis of the scientific (OSA) Silicon supports the evidence assessed, this claimed effect health of the for this food is not sufficiently defined cardiovascular system; to be able to be assessed and the Silicon helps to maintain claim could not therefore be the health of blood substantiated. vessels

2009;7(9):1269

Non-authorised

1594

2011;9(6):2259

Non-authorised

290

2009;7(9):1248

Non-authorised

358

2011;9(6):2259

Non-authorised

289

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Silicon and Silicon (as stabilized 0ligomeric orthosilicic acid (OSA)

Art.13(1) Silicon and Silicon (as stabilized 0ligomeric orthosilicic acid (OSA)

Art.13(1) Silicon

Art.13(1) Silicon

Silicon is required for Non-compliance with the Regulation Maintenance of normal healthy skin, hair and because on the basis of the scientific appearance and nails. evidence assessed, this claimed effect elasticity of the skin Silicon is beneficial for has not been linked to a function of the collagen formation in body, as required by Article 13 of the the skin; Silicon reduces Regulation. the appearance of wrinkles as it stimulates the formation of collagen and helps improve skin elasticity; Silicon is required for Non-compliance with the Regulation contribution to normal healthy skin, hair and because on the basis of the scientific formation of collagen nails. evidence assessed, this claimed effect and connective tissue Silicon is beneficial for for this food has not been collagen formation in substantiated. the skin; Silicon reduces the appearance of wrinkles as it stimulates the formation of collagen and helps improve skin elasticity; Silicon is required for Non-compliance with the Regulation maintenance of normal normal bone and because on the basis of the scientific bone connective tissue evidence assessed, this claimed effect formation. for this food has not been substantiated. Silicon is required for Non-compliance with the Regulation contribution to normal normal bone and because on the basis of the scientific formation of collagen connective tissue evidence assessed, this claimed effect and connective tissue formation. for this food has not been substantiated.

2011;9(6):2259

Non-authorised 288 (expiry of transitional period 02/01/2014)

2011;9(6):2259

Non-authorised

288

2011;9(6):2259

Non-authorised

287

2011;9(6):2259

Non-authorised

287

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

Skeletal muscle Non-compliance with the Regulation faster restoration of 2011;9(6):2225 represents the greatest because on the basis of the scientific muscle glycogen stores store of glutamine in the evidence assessed, this claimed effect after strenuous body for this food has not been exercise -muscle tissue is an substantiated. important source of glutamine -high intensity exercise decreases plasma glutamine levels -anaerobic training can deplete the glutamine pool -prolonged exercise such as marathon running decreases glutamine levels -supplementation can maintain glutamine levels during intense exercise -can abolish the exercise related decline in glutamine stores -enhances glutamine levels -restores blood glutamine levels post exercise -helps maintain optimal health after training -helps keep athletes

Non-authorised

1569

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

healthy after intense exercise -optimizing blood glutamine levels helps enhance muscle adaptation to intense exercise -reduced glutamine levels decreases the adaptive response to intense exercise -helps enhance glycogen storage -helps increase carbohydrate storage

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glutamine

Skeletal muscle Non-compliance with the Regulation faster restoration of 2011;9(6):2225 represents the greatest because on the basis of the scientific muscle glycogen stores store of glutamine in the evidence assessed, this claimed effect after strenuous body/muscle tissue is for this food has not been exercise an important source of substantiated. glutamine/high intensity exercise decreases plasma glutamine levels anaerobic training can deplete the glutamine pool/prolonged exercise such as marathon running decreases glutamine levels/supplementation can maintain glutamine levels during intense exercise/can abolish the exercise related decline restores blood glutamine levels post exercise/helps maintain optimal health after training/helps keep athletes healthy after intense exercise/optimizing blood glutamine levels helps enhance muscle adaptation to intense exercise /reduced glutamine

Non-authorised

699

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Casein

Art.13(1) Sodium bicarbonate

Art.13(1) Sodium

levels decreases the adaptive response to intense exercise/helps enhance glycogen storage/helps increase carbohydrate storage Slower absorbing Non-compliance with the Regulation growth or maintenance 2011;9(6):2213 protein source to deliver because on the basis of the scientific of muscle mass essential amino acids to evidence assessed, this claimed effect muscles for exercise for this food has not been recovery substantiated. Post-exercise consumption supports muscle anabolism Sodium bicarbonate can Non-compliance with the Regulation Reducing gastric acid 2010;8(2):1472 reduce acid levels in the because on the basis of the scientific levels stomach evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation. Sodium is needed for Non-compliance with the Regulation Maintenance of normal 2011;9(6):2260 the functioning of because this claim is contrary to the muscle function muscles. general principles for health claims. The use of this claim is considered misleading as it contradicts generally accepted scientific advice, European, national and international authorities informing the consumer to reduce intake of this substance and would therefore convey a conflicting and confusing message to consumers.

Non-authorised

1498

Non-authorised

1653

Non-authorised

359

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Emblica officinalis (Indian Softens the mucous Gooseberry) membrane of throat

Art.13(1) Soluble dietary fibre

Art.13(1) Bran

Art.13(1) Armoracia rusticana

Art.13(1) PROPOLIS

Non-compliance with the Regulation relief in case of irritation 2011;9(6):2248 because on the basis of the scientific in the upper respiratory evidence assessed, this claimed effect tract for this food has not been substantiated. Soluble dietary fibres as Non-compliance with the Regulation not validated 2010;8(10):1735 a part of the healthy diet because on the basis of the scientific could contribute to the evidence assessed, this food is not maintenance of the sufficiently characterised for a health of heart and scientific assessment of this claimed circulatory system. effect and the claim could not therefore be substantiated. Soodustab seedimist. Non-compliance with the Regulation Digestive function 2011;9(6):2228 Clarification provided because on the basis of the scientific Consumption of bran evidence assessed, this claimed effect improves digestive for this food is not sufficiently defined function to be able to be assessed and the claim could not therefore be substantiated. Soothes the digestive Non-compliance with the Regulation Gut health 2011;9(6):2228 tract/ because on the basis of the scientific /helps support the evidence assessed, this claimed effect digestive system for this food is not sufficiently defined /a source of mucilage to be able to be assessed and the which support the claim could not therefore be mucous membranes substantiated. Soothes the stomach Non-compliance with the Regulation not validated 2010;8(10):1810 and gut because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

2435

Non-authorised

810

Non-authorised

1267

Non-authorised

2223

Non-authorised

1247

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Ascorbic acid

Soothing for mouth and Non-compliance with the Regulation relief in case of irritation 2009;7(9):1226 throat / Reliefs in case because on the basis of the scientific in the upper respiratory of tickle in the throat evidence assessed, this claimed effect tract and pharynx / Soothing for this food has not been and pleasant effect on substantiated. throat, pharynx and vocal cords Art.13(1) Ascorbic acid, sodium salt Soothing for mouth and Non-compliance with the Regulation relief in case of irritation 2009;7(9):1226 throat / Reliefs in case because on the basis of the scientific in the upper respiratory of tickle in the throat evidence assessed, this claimed effect tract and pharynx / Soothing for this food has not been and pleasant effect on substantiated. throat, pharynx and vocal cords Art.13(1) Ribes nigrum L. Soothing for mouth and Non-compliance with the Regulation relief in case of irritation 2011;9(6):2248 (Common name: throat / Reliefs in case because on the basis of the scientific in the upper respiratory Blackcurrant) of tickle in the throat evidence assessed, this claimed effect tract and pharynx / Soothing for this food has not been and pleasant effect on substantiated. throat, pharynx and vocal cords. Art.13(1) Glycerol Soothing for mouth and Non-compliance with the Regulation relief in case of irritation 2011;9(6):2248 throat. because on the basis of the scientific in the upper respiratory Reliefs in case of tickle evidence assessed, this claimed effect tract in the throat and for this food has not been pharynx. substantiated. Soothing and pleasant effect on throat, pharynx and vocal cords.

Non-authorised

1714

Non-authorised

1715

Non-authorised

2332

Non-authorised

1730

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Honey, including the antioxidants in honey

Art.13(1) Ananas tige

Art.13(1) Gele Royale

Soothing for the throat Non-compliance with the Regulation not validated 2010;8(2):1484 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Soulage les douleurs Non-compliance with the Regulation maintenance of normal 2011;9(6):2247 inflammatoires because on the basis of the scientific joints Clarification provided evidence assessed, this claimed effect Shows antifor this food has not been inflammatory substantiated. properties/Helps reduce inflammatory reaction in joints and muscles/Helps maintain the flexibility and mobility of the joints Soulage les douleurs Non-compliance with the Regulation reduction of 2010;8(10):1799 inflammatoires Action because on the basis of the scientific inflammation anti-inflammatoire evidence assessed, this claimed effect Clarification provided for this food is not a beneficial Shows antiphysiological effect as required by the inflammatory Regulation. properties/Helps to manage antiinflammatory responses in the body/helps to reduce inflammation in joints and muscles.

Non-authorised

1161

Non-authorised

2514

Non-authorised

1327

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Cartilage de requin

Art.13(1) Gele Royale

Art.13(1) Saumon

Souplesse et mobilit Non-compliance with the Regulation maintenance of normal 2011;9(6):2247 des articulations - Bien- because on the basis of the scientific joints tre des articulations evidence assessed, this claimed effect for this food has not been substantiated. Soutient la circulation Non-compliance with the Regulation not validated 2011;9(4):2083 Aide matriser le because on the basis of the scientific cholestrol evidence assessed, this food is not Bon pour le cholestrol sufficiently characterised for a Clarification provided scientific assessment of this claimed Soutient la circulation effect and the claim could not therefore Aide matriser le be substantiated. cholestrol Bon pour le cholestrol Soutient la circulation Non-compliance with the Regulation maintenance of normal 2010;8(10):1796 Aide matriser le because on the basis of the scientific blood LDL-cholesterol cholestrol Harmonise evidence assessed, this claimed effect concentrations les fonctions cardiofor this food has not been vasculaires substantiated.

Non-authorised

1981

Non-authorised

1329

Non-authorised

1325

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Germe de bl

Soutient la circulation. Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 Stimule la circulation. because on the basis of the scientific (fasting) blood Aide matriser le evidence assessed, this claimed effect concentrations of cholestrol. for this food has not been triglycerides Harmonise les fonctions substantiated. cardio-vasculaires. Stimule la diminution des triglycrides. Clarification provided Helps to control blood levels of cholesterol and triglycerides Contributes to a healthy cholesterol, triglycerides levels and healthy blood vessels. Contributes to a normal blood pressure.

Non-authorised

2618

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Germe de bl

Art.13(1) Oligomres Procyanidoliques (OPC) de raisin

Soutient la circulation. Non-compliance with the Regulation maintenance of normal 2010;8(10):1762 Stimule la circulation. because on the basis of the scientific blood cholesterol Aide matriser le evidence assessed, this claimed effect concentrations cholestrol. for this food has not been Harmonise les fonctions substantiated. cardio-vasculaires. Stimule la diminution des triglycrides. Clarification provided Helps to control blood levels of cholesterol and triglycerides Contributes to a healthy cholesterol, triglycerides levels and healthy blood vessels. Contributes to a normal blood pressure. Soutient les Non-compliance with the Regulation improvement of visual 2011;9(6):2250 performances visuelles because on the basis of the scientific adaptation to the dark Renforce les fonctions evidence assessed, this claimed effect visuelles for this food has not been Clarification provided substantiated. Grapeseeds extract improve visual adaptation to low luminance /participate to the visual performance/protect cornea/supports visual function.

Non-authorised

2618

Non-authorised

680

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soy Glycine max

Art.13(1) Soy protein

Art.13(1) Soya Isoflavones

Soy helps maintain well- Non-compliance with the Regulation Reduction of vasomotor 2011;9(7):2264, being during because on the basis of the scientific symptoms associated 2012;10(8):2847 menopause evidence assessed, the evidence with menopause Soy can positively affect provided is insufficient to substantiate the well-being during this claimed effect for this food. menopause Soy helps to control Non-compliance with the Regulation maintenance of normal 2010;8(10):1812 cholesterol. l. 25 g soy because on the basis of the scientific blood cholesterol protein daily as part of a evidence assessed, this claimed effect concentrations diet with few saturated for this food has not been fatty acids helps to substantiated. maintain healthy cholesterol levels. Soya isoflavones act Non-compliance with the Regulation maintenance of normal 2011;9(7):2264 as/are phyto-estrogens. because on the basis of the scientific blood LDL-cholesterol Contains evidence assessed, this claimed effect concentrations phytoestrogens Added for this food has not been goodness of soya substantiated. isoflavones, which act as phytoestrogens. Added goodness of soya phytoestrogens Contains soya isoflavones, which act as phytoestrogens

Non-authorised 2140 (expiry of transitional period 02/01/2014)

Non-authorised

556

Non-authorised

3093

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Soya Isoflavones

Soya isoflavones act Non-compliance with the Regulation Reduction of vasomotor 2011;9(7):2264, as/are phyto-estrogens. because on the basis of the scientific symptoms associated 2012;10(8):2847 Contains evidence assessed, the evidence with menopause phytoestrogens Added provided is insufficient to substantiate goodness of soya this claimed effect for this food. isoflavones, which act as phytoestrogens. Added goodness of soya phytoestrogens Contains soya isoflavones, which act as phytoestrogens Art.13(1) soyfoods (isoflavones) Soyfoods naturally Non-compliance with the Regulation protection of DNA, 2011;9(7):2264 contain antioxidants because on the basis of the scientific proteins and lipids from (isoflavones) which help evidence assessed, this claimed effect oxidative damage the body to fight free for this food has not been radicals. substantiated. Art.13(1) Probiotics & Prebiotics as Specially formulated for Non-compliance with the Regulation not validated 2009;7(9):1247 contained in the probiotic infants and children to because on the basis of the scientific formula ProbioStart: support healthy evidence assessed, this food is not Bifidobacterium infantis digestion and immunity. sufficiently characterised for a (CNCM I-3424), For Pregnant and scientific assessment of this claimed Bifidobacterium bifidum breastfeeding women to effect and the claim could not therefore (CNCM I-3426), maintain healthy levels be substantiated. Lactobacillus acidophilus of the appropriate types (CNCM I-1722), of beneficial bacteria for Fructooligosaccharides. child health A unique probiotic & prebiotic blend

Non-authorised 3093 (expiry of transitional period 02/01/2014)

Non-authorised

4245

Non-authorised

929

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) squalene idrocarburo

Art.13(1) Flaxseed oil

Art.13(1) Stearic acid

Art.13(1) Royal jelly

Art.13(1) L/methionine

Squalen, in the sebum Non-compliance with the Regulation Protection of DNA, of the skin acts as because on the basis of the scientific proteins and lipids from antioxidant and protects evidence assessed, this claimed effect oxidative damage the skin from damages for this food has not been produced by UV rays substantiated. Stabilises moods. Non-compliance with the Regulation Enhancement of mood because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Stearic acid helps to Non-compliance with the Regulation maintenance of normal maintain a balanced because on the basis of the scientific blood cholesterol blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Stimulates blood Non-compliance with the Regulation not validated circulation because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Stimulates hair growth. / Non-compliance with the Regulation maintenance of normal Arrests hair loss and because on the basis of the scientific hair degradation evidence assessed, this claimed effect for this food has not been substantiated.

2010;8(2):1489

Non-authorised

1706

2011;9(4):2050

Non-authorised

578

2010;8(2):1476

Non-authorised

716, 1657

2011;9(4):2083

Non-authorised

1227

2010;8(10):1795

Non-authorised

4686

Generated on: 28/01/2014 09:37 AM

Page 693

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Ganoderma lucidumMashroom-Reishi mushroom

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Stimulates the body in Non-compliance with the Regulation Physical well-being exhaustion because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Oenothera biennis-eveninigStimulates the Non-compliance with the Regulation maintenance of normal primrose-seeds oil catabolism of saturated because on the basis of the scientific blood LDL-cholesterol lipids. / Contributes to evidence assessed, this claimed effect concentrations body weight reducing. / for this food has not been Helpful in reducing the substantiated. adipose level and prevents arteriosclerosis. D-Tagatose Stimulates the growth of Non-compliance with the Regulation decreasing potentially beneficial bacteria in the because on the basis of the scientific pathogenic gastrogut evidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated. D-Tagatose Stimulates the growth of Non-compliance with the Regulation increasing numbers of beneficial bacteria in the because on the basis of the scientific gastro-intestinal gut evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation. Quinoa (Chenopodium Stimulation of the hair Non-compliance with the Regulation maintenance of hair quinoa) bulb, favouring the because on the basis of the scientific growth of the hair evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2228

Non-authorised

4407

2011;9(4):2059

Non-authorised

4452

2010;8(10):1809

Non-authorised

1905

2010;8(10):1809

Non-authorised

1905

2009;7(9):1285

Non-authorised

2746

Generated on: 28/01/2014 09:37 AM

Page 694

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bacterial lysate

Strenghtens the body's natural resistance/supports the immune function

Art.13(1) Creatine

Art.13(1) Brewer`s Yeast

Art.13(1) Sea buckthorn berry oil (cold-pressed)

Non-compliance with the Regulation immune 2010;8(10):1799 because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Strengthens /supports Non-compliance with the Regulation increase in endurance 2011;9(7):2303 /assists human energy because on the basis of the scientific performance reserves Supports the evidence assessed, this claimed effect building of muscle for this food has not been Supports the building of substantiated. muscle improves physical performance Strengthens immunity Non-compliance with the Regulation immune 2010;8(10):1799 because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Strengthens immunity Non-compliance with the Regulation Immune 2011;9(4):2061 because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

Non-authorised

1451

Non-authorised

1521

Non-authorised

1384

Non-authorised

586

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Page 695

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Shark liver oil/alkylglycerol Strengthens immunity

Non-compliance with the Regulation immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lactobacillus johnsonii BFEStrengthens skin Non-compliance with the Regulation skin health 6128 defences because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Herbal yeast plasmolycate Strengthens the bodys Non-compliance with the Regulation Immune (saccharomyces defence system. because on the basis of the scientific function/immune cerevisiae) Increases immunity evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Brewer`s Yeast Strengthens the Non-compliance with the Regulation Cardiovascular health cardiovascular system, because on the basis of the scientific is necessary for blood evidence assessed, this claimed effect formation for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1799

Non-authorised

1851

2011;9(4):2026

Non-authorised

991

2011;9(4):2061

Non-authorised

1817

2011;9(6):2228

Non-authorised

1382

Generated on: 28/01/2014 09:37 AM

Page 696

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat germ oil

Strengthens the digestive system.

Art.13(1) Lecithin

Strengthens the immune system of the body

Non-compliance with the Regulation "digestive system" because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation Immune because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1762

Non-authorised

1388

2011;9(4):2061

Non-authorised

1778

Generated on: 28/01/2014 09:37 AM

Page 697

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Emblica officinalis FRUIT Strengthens the Non-compliance with the Regulation protection of DNA, 2011;9(6):2217 RIND immune systen. because on the basis of the scientific proteins and lipids from Strengthens the body's evidence assessed, this claimed effect oxidative damage natural defenses. for this food has not been -Strengthens the body's substantiated. natural defenses. Helps maintain the immune system, the body's natural defenses. Contains a high amount of naturally occurring antioxidants -Antioxidants help protect you from radicals which cause cell damage/antioxidants help protect your cells, tissues and organs from oxidative damage Antioxidants contribute to the total antioxidant capacity of the body and may help strengthen your body's defences. Helps protect your body's cells, tissues and organs.

Non-authorised

4042

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat germ oil

Non-compliance with the Regulation contribution to normal 2010;8(10):1762 because on the basis of the scientific neurological function evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Lactobacillus paracasei Strengthens/supports Non-compliance with the Regulation not validated 2009;7(9):1247 ssp. paracasei CRL-431 your body's natural because on the basis of the scientific (=L. casei 431)and defence evidence assessed, this food is not Lactobacillus acidophilus Strengthens/supports sufficiently characterised for a the immune system scientific assessment of this claimed Strengthens and effect and the claim could not therefore protects from inside be substantiated. Art.13(1) Soy + magnesium + Strong bones. The best Non-compliance with the Regulation maintenance of normal 2011;9(6):2247 calcium + zinc + for your bones. Good because on the basis of the scientific bone manganese + copper + ageing. The soy evidence assessed, this claimed effect vitamin B6 + vitamin D + flavones and mineral for this food has not been vitamin K substances, calcium, substantiated. magnesium, zinc, manganese and copper, together with vitamins B6, D and K protect the bones. Name or symbol included in the claim: Osteobalans Art.13(1) CLA or conjugated linoleic Strong plant antioxidant. Non-compliance with the Regulation protection of DNA, 2010;8(10):1794 acid Antioxidant. because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Strengthens the nervous system

Non-authorised

1387

Non-authorised

922

Non-authorised

1860

Non-authorised

564

Generated on: 28/01/2014 09:37 AM

Page 699

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat sprouts

Art.13(1) Wheat sprouts

Art.13(1) Sugar beet fibre

Art.13(1) Sugar beet fibre

Art.13(1) L-Cystine/;cysteine

Art.13(1) L-Methionine

Strong plant antioxidant. Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 Protect cells from because on the basis of the scientific content, and antioxidant premature ageing. evidence assessed, this claimed effect properties for this food is not a beneficial physiological effect as required by the Regulation. Strong plant antioxidant. Non-compliance with the Regulation Protection of cells from 2010;8(2):1489 Protect cells from because on the basis of the scientific premature aging premature ageing. evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Sugar beet fibre helps Non-compliance with the Regulation maintenance of normal 2011;9(4):2034 to balance blood sugar because on the basis of the scientific blood glucose levels. evidence assessed, this claimed effect concentrations for this food has not been substantiated. Sugar beet fibre helps Non-compliance with the Regulation reduction of post2011;9(4):2034 to balance blood sugar because on the basis of the scientific prandial glycaemic levels. evidence assessed, this claimed effect responses for this food has not been substantiated. Sulfur-containing amino Non-compliance with the Regulation maintenance of normal 2010;8(10):1795 acids could contribute to because on the basis of the scientific skin the maintenance of the evidence assessed, this claimed effect healthy structure of hair, for this food has not been nails and skin.; substantiated. Sulfur-containing amino Non-compliance with the Regulation maintenance of normal 2010;8(10):1795 acids could contribute to because on the basis of the scientific skin the maintenance of the evidence assessed, this claimed effect healthy structure of hair, for this food has not been nails and skin.; substantiated.

Non-authorised

2832

Non-authorised

2832

Non-authorised

752

Non-authorised

752

Non-authorised

665

Non-authorised

666, 1916

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Natural mineral water: Sulphates as Mg-, Nasalts: MgSO4, Na2SO4

Sulphates promote emptying of bowel.

Art.13(1) Superoxide dismutase (SOD)

Art.13(1) Beta-alanine

Art.13(1) Beta-alanine

Non-compliance with the Regulation changes in bowel 2011;9(6):2246 because on the basis of the scientific function evidence assessed, this claimed effect for this food has not been substantiated. Superoxide dismutase Non-compliance with the Regulation protection of DNA, 2010;8(10):1753 has an antioxidant because on the basis of the scientific proteins and lipids from activity and may help to evidence assessed, this claimed effect oxidative damage protect the body for this food has not been substantiated. Supplementation helps Non-compliance with the Regulation increase in time to 2010;8(10):1729 improve exercise because on the basis of the scientific exhaustion performance and evidence assessed, this claimed effect cycling performance. for this food has not been Helps reduce muscle substantiated. fatigue. Supplementation helps Non-compliance with the Regulation increase in time to 2010;8(10):1729 improve exercise because on the basis of the scientific exhaustion performance. evidence assessed, this claimed effect Helps reduce muscle for this food has not been fatigue. substantiated. Helps improve muscle work capacity. Contributes to the increase of muscle buffering capacity, which is directly related to muscle carnosine stores. Helps maintain optimal muscle pH during exercise.

Non-authorised

2885

Non-authorised

1970

Non-authorised

683

Non-authorised

1452

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Manganese

Art.13(1) Phosphorus

Art.13(1) Thiamin (B1)

Art.13(1) Zinc

Supplementation with B Non-compliance with the Regulation reduction of tiredness -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status Supplementation with B Non-compliance with the Regulation Reduction of tiredness -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status Supplementation with B Non-compliance with the Regulation reduction of tiredness -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status Supplementation with B Non-compliance with the Regulation reduction of tiredness -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status

2010;8(10):1808

Non-authorised

312

2011;9(4):2080

Non-authorised

323

2010;8(10):1755

Non-authorised

23

2010;8(10):1819

Non-authorised

304

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Page 702

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Calcium

Art.13(1) Chromium (III)

Art.13(1) Copper

Supplementation with B Non-compliance with the Regulation reduction of tiredness 2010;8(10):1725 -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status. Supplementation with B Non-compliance with the Regulation reduction of tiredness 2010;8(10):1732 -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status. Supplementation with B Non-compliance with the Regulation Reduction of tiredness 2011;9(4):2079 -vitamins, iron, because on the basis of the scientific and fatigue magnesium as well as evidence assessed, this claimed effect vitamin C can reduce for this food has not been fatigue and tiredness in substantiated. situations of inadequate micro-nutrient status.

Non-authorised

232

Non-authorised

261

Non-authorised

272

Generated on: 28/01/2014 09:37 AM

Page 703

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) HMB (B-hydroxy Bmethylbutyrate monohydrate)

Art.13(1) Soy protein

Art.13(1) Policosanol [from sugarcane wax (Saccarum officinarum)]

Supplementing with Non-compliance with the Regulation increase in lean body 2011;9(6):2227 HMB may help improve because on the basis of the scientific mass body composition evidence assessed, this claimed effect HMB supports for this food has not been maintenance of lean substantiated. muscle mass With proper diet and exercise, HMB can help support an increase in fat free mass. HMB has been shown to increase lean muscle mass Support antioxidant Non-compliance with the Regulation protection of DNA, 2010;8(10):1812 status because on the basis of the scientific proteins and lipids from Radicals associated evidence assessed, this claimed effect oxidative damage with exercise for this food has not been substantiated. Support for Healthy Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 Blood Lipid Levels/ because on the basis of the scientific blood HDL-cholesterol Natural Blood Lipid evidence assessed, this claimed effect concentrations Support/ Policosanol for this food has not been supports healthy lipid substantiated. metabolism/ Policosanol may promote LDL binding, uptake, and degradation/ Policosanol may help maintain healthy blood pressure levels already within normal range

Non-authorised

1579

Non-authorised

435

Non-authorised

1748

Generated on: 28/01/2014 09:37 AM

Page 704

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Policosanol [from sugarcane wax (Saccarum officinarum)]

Art.13(1) Conjugated linoleic acid (CLA)

Art.13(1) Phosphatidyl serine

Support for Healthy Non-compliance with the Regulation maintenance of normal 2011;9(6):2255 Blood Lipid Levels/ because on the basis of the scientific blood LDL-cholesterol Natural Blood Lipid evidence assessed, this claimed effect concentrations Support/ Policosanol for this food has not been supports healthy lipid substantiated. metabolism/ Policosanol may promote LDL binding, uptake, and degradation/ Policosanol may help maintain healthy blood pressure levels already within normal range Support of (HepB) Non-compliance with the Regulation contribution to immune 2010;8(10):1794 vaccine response/Helps because on the basis of the scientific defences by stimulation respiratory comfort in evidence assessed, this claimed effect of production of asthma for this food has not been protective antibodies in substantiated. response to vaccination Support of cognitive Non-compliance with the Regulation not validated 2010;8(10):1749 functions in young because on the basis of the scientific people evidence assessed, this food is not Contributes to the sufficiently characterised for a maintenance of scientific assessment of this claimed cognitive functions with effect and the claim could not therefore aging be substantiated. Supports memory and brain performance in aging adults

Non-authorised

1748

Non-authorised

687, 1519

Non-authorised

1632

Generated on: 28/01/2014 09:37 AM

Page 705

820

EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Phosphatidylserine

Art.13(1) Apium graveolens

Support of cognitive Non-compliance with the Regulation not validated 2010;8(10):1749 functions in young because on the basis of the scientific people evidence assessed, this food is not Contributes to the sufficiently characterised for a maintenance of scientific assessment of this claimed cognitive functions with effect and the claim could not therefore aging be substantiated. Supports memory and brain performance in aging adults Plays an important role in healthy nerve function through the central nervous system including the brain Contributes to the resistance against stress Helps concentration and mental performance in cases of stress. Support of normal Non-compliance with the Regulation Kidneys health, 2010;8(10):1742 bladder function because on the basis of the scientific urinary health, evidence assessed, this claimed effect bladder health, health for this food is not sufficiently defined of lower urinary tract, to be able to be assessed and the blood health, claim could not therefore be elimination, "urinary substantiated. system benefits" and/or supports/promotes the excretory function of the kidney

Non-authorised

734

Non-authorised

2217

Generated on: 28/01/2014 09:37 AM

Page 706

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Arginine

Art.13(1) Arginine

Art.13(1) Arginine

Art.13(1) Black currant (Ribes nigrum L.)

Support of normal blood Non-compliance with the Regulation Improvement of 2011;9(4):2051 circulation because on the basis of the scientific endothelium-dependent evidence assessed, this claimed effect vasodilation for this food has not been substantiated. Support of normal blood Non-compliance with the Regulation Maintenance of normal 2011;9(4):2051 circulation because on the basis of the scientific blood pressure evidence assessed, this claimed effect for this food has not been substantiated. Support of normal blood Non-compliance with the Regulation Normal red blood cell 2011;9(4):2051 circulation because on the basis of the scientific formation evidence assessed, this claimed effect for this food has not been substantiated. Support of venous Non-compliance with the Regulation Vascular and vein 2011;9(6):2228 circulation because on the basis of the scientific health Helps to reduce the evidence assessed, this claimed effect feeling of tired and for this food is not sufficiently defined heavy legs to be able to be assessed and the Helps to maintain claim could not therefore be healthy leg-vein substantiated. functions Promotes circulatory well-being Favourable influence on the blood circulation For legs relief and to favour comfort

Non-authorised

1443

Non-authorised

1443

Non-authorised

1443

Non-authorised

4278

Generated on: 28/01/2014 09:37 AM

Page 707

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Alpha Lipoic acid (ALA)

Support the healthy Non-compliance with the Regulation Regeneration of genes, 2010;8(2):1474 metabolism of genes in because on the basis of the scientific regeneration of gene organism. evidence assessed, this claimed effect transcription and the for this food has not been influence to activity NFsubstantiated. kapa B Art.13(1) Vitamin E acetate (D,LSupport the Non-compliance with the Regulation maintenance of a 2010;8(10):1816 alpha tocopherol acetate) microcirculation and the because on the basis of the scientific normal scalp oxygenation of the evidence assessed, this claimed effect scalp. for this food has not been substantiated. Art.13(1) A combination of the Support your natural Non-compliance with the Regulation not validated 2009;7(9):1247 probiotics: Lactobacillus defence. because on the basis of the scientific casei F19, Lactobacillus Helps your bodys evidence assessed, this food is not plantarum 2592, natural defence. sufficiently characterised for a Leuconostoc Supports the immune scientific assessment of this claimed mesenteroides 77:1, system. effect and the claim could not therefore Pediococcus pentosaceus Contains the probiotics be substantiated. 16:1 Lactobacillus casei F19, Lactobacillus plantarum 2592, Leuconostoc mesenteroides 77:1, Pediococcus pentosaceus 16:1 Art.13(1) Beta carota (carrot juice, Supports a healthy Non-compliance with the Regulation reduction of gastro2011;9(6):2248 lactic acid fermented) digestion because on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

3133

Non-authorised

2873

Non-authorised

1090

Non-authorised

3075

Generated on: 28/01/2014 09:37 AM

Page 708

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta vulgaris (red beet Supports a healthy juice, lactic acid fermented) digestion

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation reduction of gastrobecause on the basis of the scientific intestinal discomfort evidence assessed, this claimed effect for this food has not been substantiated. Beta carota (carrot juice, Supports a healthy Non-compliance with the Regulation Intestinal flora lactic acid fermented) intestinal and colon flora because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Beta vulgaris (red beet Supports a healthy Non-compliance with the Regulation decreasing potentially juice, lactic acid fermented) intestinal and colon flora because on the basis of the scientific pathogenic gastroevidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated. Beta vulgaris (red beet Supports a healthy Non-compliance with the Regulation increasing numbers of juice, lactic acid fermented) intestinal and colon flora because on the basis of the scientific gastro-intestinal evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation. Lactobacillus parcasei 02A Supports a healthy Non-compliance with the Regulation not validated (DSM 13432) intestinal flora because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2248

Non-authorised

3072

2011;9(6):2228

Non-authorised

3076

2010;8(10):1767

Non-authorised

3073

2010;8(10):1767

Non-authorised

3073

2009;7(9):1247

Non-authorised

1075

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum 299 (DSM 6595, 67B)

Supports a healthy intestinal flora

Art.13(1) Lactobacillus plantarum 299v (DSM 9843)

Supports a healthy intestinal flora

Art.13(1) Lactobacillus rhamnosus 271 (DSM 6594)

Supports a healthy intestinal flora

Art.13(1) Lactobacillus reuteri DSM Supports a healthy oral 17938 Lactobacillus reuteri flora ATCC PTA 5289

Art.13(1) Astaxanthin from Haematococcus pluvialis

Supports anti-aging through cellular health. Supports a healthy response to physiologic al stress. Supports healthy immune function. Protects DNA.

Non-compliance with the Regulation decreasing potentially because on the basis of the scientific pathogenic intestinal evidence assessed, this claimed effect microorganisms for this food has not been substantiated. Non-compliance with the Regulation decreasing potentially because on the basis of the scientific pathogenic intestinal evidence assessed, this claimed effect microorganisms for this food has not been substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation Immune system because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1726

Non-authorised

1078

2009;7(9):1242

Non-authorised

1084

2009;7(9):1247

Non-authorised

1076

2009;7(9):1247

Non-authorised

1089

2011;9(6):2206

Non-authorised

1919

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Astaxanthin from Haematococcus pluvialis

Supports anti-aging through cellular health. Supports a healthy response to physiological stress. Supports healthy immune function. Protects DNA. Art.13(1) Astaxanthin from Supports anti-aging Haematococcus pluvialis through cellular health. Supports increased energylevels. Helps control excessive free radicals in the body. Supports ahealthy response to oxidative stress. Protects DNA from free radicals. Art.13(1) Aegle marmelos UNRIPE Supports digestion and FRUIT metabolism of carbohydrates and lipids

Non-compliance with the Regulation Immune system because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2206

Non-authorised

1980

Non-compliance with the Regulation protection of DNA, 2009;7(9):1253 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

1449

Non-compliance with the Regulation Improvement of the 2011;9(6):2228 because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation.

Non-authorised

3972

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Coenzyme Q10 (Ubiquinone);

Supports energy Non-compliance with the Regulation contribution to normal production -is because on the basis of the scientific energy-yielding needed/important for evidence assessed, this claimed effect metabolism energy production in the for this food has not been cell -plays an important substantiated. role in the ATP production to maintain healthy condition -is needed/important for the energy metabolism and the transformation of food into physiological Art.13(1) Emblica officinalis FRUIT Supports eye function Non-compliance with the Regulation maintenance of normal RIND because on the basis of the scientific vision evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Astaxanthin from Supports healthy Non-compliance with the Regulation maintenance of blood Haematococcus pluvialis cholesterol levels. because on the basis of the scientific cholesterol Maintains low C evidence assessed, this claimed effect concentrations and reactive protein levels for this food has not been maintenance of low substantiated. plasma concentrations of C-reactive protein Art.13(1) Combination of millet Supports healthy hair Non-compliance with the Regulation not validated extract + L-cystine + growth from within. because on the basis of the scientific vitamin B5 (calcium Supports the growth of evidence assessed, this food is not panthothenate) healthy hair & nails. sufficiently characterised for a Supports metabolism of scientific assessment of this claimed the hair roots. effect and the claim could not therefore be substantiated.

2010;8(10):1793

Non-authorised

1508

2011;9(6):2248

Non-authorised

4044

2009;7(9):1253

Non-authorised

1450

2011;9(6):2244

Non-authorised

1514

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Emblica officinalis FRUIT Supports heart function Non-compliance with the Regulation maintenance of normal RIND and blood quality. because on the basis of the scientific blood LDL-cholesterol Contributes to normal evidence assessed, this claimed effect concentrations cholesterol. Contributes for this food has not been to the health of the substantiated. cardiovascular system Art.13(1) Soy proteins Supports in weight loss Non-compliance with the Regulation contribution to the programs. because on the basis of the scientific maintenance or Contributes to body evidence assessed, this claimed effect achievement of a weight control. for this food has not been normal body weight Helps to loose fat mass substantiated. without losing lean mass. Contributes to weight loss without losing muscle mass. Helps in fat mass loss while preserving lean mass Art.13(1) Milk fat globule Supports intestinal Non-compliance with the Regulation reduction of gastromembrane/Milk comfort. because on the basis of the scientific intestinal discomfort phospholipids Supports the functioning evidence assessed, this claimed effect of the digestive system. for this food has not been substantiated. Art.13(1) Shark cartilage + Supports joint Non-compliance with the Regulation maintenance of normal greenshell mussel functioning. because on the basis of the scientific joints For joint health. evidence assessed, this claimed effect Supports joint wellfor this food has not been being substantiated.

2011;9(6):2217

Non-authorised

4041

2010;8(10):1812

Non-authorised

598

2011;9(6):2248

Non-authorised

644, 1742

2011;9(6):2247

Non-authorised

1855

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Astaxanthin from Haematococcus pluvialis

Art.13(1) Astaxanthin from Haematococcus pluvialis

Art.13(1) Sodium Hyaluronate

Supports joint health. Supports Healthy Tendons. Supports Healthy Carpal Tunnel. Supports joint function after heavy exercise Supports joint health. Supports Healthy Tendons. Supports Healthy Carpal Tunnel. Supports joint function after heavy exercise. Supports joint mobility.

Non-compliance with the Regulation maintenance of joints, 2009;7(9):1253 because on the basis of the scientific tendons, and evidence assessed, this claimed effect connective tissue for this food has not been substantiated. Non-compliance with the Regulation maintenance of joints, 2009;7(9):1253 because on the basis of the scientific tendons, and evidence assessed, this claimed effect connective tissue for this food has not been substantiated. Non-compliance with the Regulation maintenance of joints because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation improvement of because on the basis of the scientific memory evidence assessed, this claimed effect for this food has not been substantiated. 2009;7(9):1266

Non-authorised

1918

Non-authorised

1978

Non-authorised

1932

Art.13(1) amino acid phenylalanine Supports memory (found naturally in the breast milk of mammals and manufactured for food and drink products) phenylalanine Art.13(1) Emblica officinalis FRUIT Supports mental Non-compliance with the Regulation relief from stressRIND function. Helps maintain because on the basis of the scientific induced headache freedom from pain in evidence assessed, this claimed effect the head. Improves the for this food has not been body's resistance to substantiated. stress. Helps the body to deal with stress

2010;8(10):1748

Non-authorised

658

2011;9(6):2248

Non-authorised

4037

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus plantarum 299 (DSM 6595, 67B)

Supports natural/body defence

Art.13(1) Coenzyme Q10 (Ubiquinone); Normal cardiovascular function

Art.13(1) Papain

Art.13(1) PROPOLIS

Non-compliance with the Regulation immune system because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Supports normal blood Non-compliance with the Regulation maintenance of normal pressure Contributes to because on the basis of the scientific blood pressure a normal blood pressure evidence assessed, this claimed effect for this food has not been substantiated. Supports normal Non-compliance with the Regulation Immune immune function because on the basis of the scientific function/immune /supports body own evidence assessed, this claimed effect system defence mechanisms for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Supports oral health. Non-compliance with the Regulation not validated Maintains health of because on the basis of the scientific teeth and gums evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1241

Non-authorised

1077

2010;8(10):1793

Non-authorised

1509

2011;9(4):2061

Non-authorised

1628

2010;8(10):1810

Non-authorised

1645

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Papaya

Art.13(1) Astaxanthin from Haematococcus pluvialis

Supports pancreas activity and protein break-up. Papaya breaks down proteins and relieves after a heavy meal and when traveling in areas with different food hygiene. The papain enzymes in papaya break down proteins and activates digestive enzymes. Supports skin structure during sun exposure. Supports healthy skin.

Non-compliance with the Regulation Improvement of the 2011;9(6):2228 because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation.

Non-authorised

2825

Art.13(1) Eicosapentaenoic acid (EPA)

Supports the ability to concentrate. Supports learning abilities. EPA helps to calm down. EPA offers rest for mind and body.

Non-compliance with the Regulation protection of the skin because on the basis of the scientific from UV-induced evidence assessed, this claimed effect damage for this food has not been substantiated. Non-compliance with the Regulation calming because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2206

Non-authorised

1979

2010;8(10):1736

Non-authorised

634

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Eicosapentaenoic acid (EPA)

Supports the ability to Non-compliance with the Regulation increased attention concentrate. because on the basis of the scientific Supports learning evidence assessed, this claimed effect abilities. for this food has not been EPA helps to calm substantiated. down. EPA offers rest for mind and body. Art.13(1) Beta-glucan + olive leaf Supports the bodys Non-compliance with the Regulation Immune extract own defence because on the basis of the scientific function/immune mechanism / immunity evidence assessed, this claimed effect system Maintains natural for this food is not sufficiently defined defence mechanism / to be able to be assessed and the immunity claim could not therefore be Helps strengthen substantiated. natural immunity Art.13(1) Lactobacilus acidophilus, Supports the bodys Non-compliance with the Regulation not validated Lactobacillus paracasei , own defence because on the basis of the scientific Lactobacillus rhamnosus mechanism /immunity evidence assessed, this food is not and Bifidobacterium lactis sufficiently characterised for a lactic acid bacteria Maintains natural scientific assessment of this claimed defence mechanism effect and the claim could not therefore /immunity be substantiated. Helps strengthen natural immunity Probiotic

2010;8(10):1736

Non-authorised

634

2011;9(4):2061

Non-authorised

1793

2009;7(9):1247

Non-authorised

1056

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Green coffea (Coffea arabica L.)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Supports the Non-compliance with the Regulation Increase in renal water detoxification function. because on the basis of the scientific elimination Supports kidney and evidence assessed, this claimed effect liver functions. May help for this food is not a beneficial the detoxification physiological effect as required by the process. Promotes Regulation. urinary elimination. Emblica officinalis FRUIT Supports the digestion Non-compliance with the Regulation Maintenance of normal RIND and metabolism of because on the basis of the scientific blood glucose sugars. Helps to evidence assessed, this claimed effect concentrations maintain normal blood for this food has not been glucose level. substantiated. Asparagus officinalis Supports the excretory Non-compliance with the Regulation Increase in renal water function of the kidneys because on the basis of the scientific elimination /contributes to urinary evidence assessed, this claimed effect flow for this food is not a beneficial physiological effect as required by the Regulation. Astaxanthin from Supports the eyes. Non-compliance with the Regulation maintenance of visual Haematococcus pluvialis Visual acuity support. because on the basis of the scientific acuity Provides antioxidant evidence assessed, this claimed effect support to the retina. for this food has not been substantiated. Shark cartilage, powder Supports the immune Non-compliance with the Regulation immune and extract response because on the basis of the scientific function/immune evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1742

Non-authorised

1232

2010;8(2):1490

Non-authorised

4043

2010;8(10):1742

Non-authorised

2228

2009;7(9):1253

Non-authorised

1448

2010;8(10):1799

Non-authorised

1854

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Probiotic strain: Lactobacillus salivarius W24

Supports the immune system

Art.13(1) Glutamine

Art.13(1) PROPOLIS

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Supports the immune Non-compliance with the Regulation stimulating system because on the basis of the scientific immunological -is an important nutrient evidence assessed, this claimed effect responses for those cells requiring for this food is not a beneficial rapid renewal such as physiological effect as required by the immune cells (e.g. Regulation. lymphocytes) -is an important fuel for rapidly dividing cells, including those of the immune system -supplementation contributes to immune function -contributes to the immune response to exercise Supports the immune Non-compliance with the Regulation not validated system and the bodys because on the basis of the scientific defence evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

2980

2011;9(6):2225

Non-authorised

1568

2010;8(10):1810

Non-authorised

3799

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) AMORPHOPHALLUS KONJAC KOCH

Supports the immune Non-compliance with the Regulation immune system and the bodys because on the basis of the scientific function/immune defence (antioxidant). evidence assessed, this claimed effect system for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Glutamine Supports the immune Non-compliance with the Regulation immune health system is a vital nutrient because on the basis of the scientific for those cells requiring evidence assessed, this claimed effect rapid renewal such as for this food has not been immune cells (e.g. substantiated. lymphocytes) is an essential fuel for rapidly dividing cells, including those of the immune system supplementation contributes to immune function contributes to the immune response to the exercise. Art.13(1) Beta vulgaris (red beet Supports the immune Non-compliance with the Regulation immune juice, lactic acid fermented) system, contains natural because on the basis of the scientific function/immune antioxidants as evidence assessed, this claimed effect system betalaine and betaine for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1799

Non-authorised

3218

2009;7(9):1235

Non-authorised

733

2010;8(10):1799

Non-authorised

3074

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Beta carota (carrot juice, lactic acid fermented)

Supports the immune system, supports the natural antioxidant system in the body

Art.13(1) Borago officinalis (CommonSupports the integrity Name : Borage) and the fluidity of the cell membrane. Plays an active role in the natural skin rejuvenation. Maintains its suppleness and elasticity/improves cutaneous barrier function in the elderly people/helps maintain transepidermal water balance Art.13(1) Pure salmon oil 500 mg. D Supports the normal alpha tocopherol10 mg.- level of blood cps cholesterol.

Non-compliance with the Regulation protection of DNA, 2011;9(6):2246 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Non-compliance with the Regulation Maintenance of the 2011;9(4):2059 because on the basis of the scientific barrier function of the evidence assessed, this claimed effect skin for this food has not been substantiated.

Non-authorised

3077

Non-authorised

2003

Art.13(1) Glucosamin 500 mg, Supports the normal chondroitin 440 mg, vit. PP synthesis of the 6 mg, Sodium selenit 4,8 conjunctive tissue of mg.cps joints.

Non-compliance with the Regulation Maintenance of normal 2011;9(4):2078 because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Non-compliance with the Regulation Maintenance of normal 2011;9(6):2247 because on the basis of the scientific joints evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

4719

Non-authorised 4718 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Emblica officinalis FRUIT Supports the Non-compliance with the Regulation Increase in renal water RIND reproductive and urinary because on the basis of the scientific elimination systems evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Lactobacillus plantarum Supports your natural / Non-compliance with the Regulation not validated HEAL 9 (DSM 15312 = body defence because on the basis of the scientific 39D) Helps to maintain a evidence assessed, this food is not normal vaginal flora sufficiently characterised for a Supports a healthy scientific assessment of this claimed intestinal flora effect and the claim could not therefore be substantiated. Art.13(1) Lactobacillus paracasei Supports your natural / Non-compliance with the Regulation decreasing potentially 8700:2 (DSM 13434, body defence Supports because on the basis of the scientific pathogenic intestinal 240HI) a healthy intestinal flora evidence assessed, this claimed effect microorganisms for this food has not been substantiated. Art.13(1) Lactobacillus plantarum Supports your Non-compliance with the Regulation "Immune system" 299v (DSM 9843) natural/body defence because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lactobacillus acidophilus Supports/promotes a Non-compliance with the Regulation not validated LAhealthy vaginal because on the basis of the scientific 5 microflora evidence assessed, this food is not Supports/promotes sufficiently characterised for a vaginal health scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1742

Non-authorised

4040

2009;7(9):1247

Non-authorised

1071

2009;7(9):1240

Non-authorised

1074

2010;8(2):1488

Non-authorised

1081

2009;7(9):1247

Non-authorised

880

Generated on: 28/01/2014 09:37 AM

Page 722

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Methylsulfonylmethane (MSM) in combination with glucosamine HCl Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Synergistic combination Non-compliance with the Regulation Maintenance of joints for joint maintenance because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Whey Protein Taken after resistance Non-compliance with the Regulation growth or maintenance exercise, whey protein because on the basis of the scientific of muscle mass supports muscle growth evidence assessed, this claimed effect for this food has not been substantiated. Hyaluronic Acid The Hyaluronic Acid in Non-compliance with the Regulation maintenance of joints Schiff Move Free because on the basis of the scientific helps lubricate and evidence assessed, this claimed effect support joints. for this food has not been substantiated. Bilberry and anthocyanins The anthocyanins from Non-compliance with the Regulation not validated from blackcurrant bilberry and mountain because on the basis of the scientific blackcurrant are good evidence assessed, this food is not for the eyes (improve sufficiently characterised for a adaptation to the dark scientific assessment of this claimed and relieve eye effect and the claim could not therefore tiredness caused by be substantiated. computer terminal work). B-caroten The antioxidant action Non-compliance with the Regulation protection of DNA, of beta-caroten helps to because on the basis of the scientific proteins and lipids from neutralize free radicals evidence assessed, this claimed effect oxidative damage and counteracts cellular for this food has not been ageing. substantiated. Beta-caroten is involved in body tissue protection from UV rays damage.

2009;7(9):1268

Non-authorised 1617 (expiry of transitional period 02/01/2014) Non-authorised 418

2010;8(10):1818

2009;7(9):1266

Non-authorised

1572

2011;9(6):2244

Non-authorised

2796

2011;9(4):2021

Non-authorised

197

Generated on: 28/01/2014 09:37 AM

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) B-caroten

Art.13(1) xanthohumol

Art.13(1) Very low calorie diet (VLCD) Programme

The antioxidant action Non-compliance with the Regulation protection of the skin 2011;9(4):2021 of beta-caroten helps to because on the basis of the scientific from UV-induced neutralize free radicals evidence assessed, this claimed effect (including photoand counteracts cellular for this food has not been oxidative) damage ageing. substantiated. Beta-caroten is involved in body tissue protection from UV rays damage. The antioxidative Non-compliance with the Regulation protection of cells from 2010;8(10):1752 properties of because on the basis of the scientific premature aging Xanthohumol evidence assessed, this claimed effect strengthen body cells in for this food is not sufficiently defined fighting oxidation to be able to be assessed and the induced aging claim could not therefore be substantiated. The composition of the Non-compliance with the Regulation reduction in the sense 2011;9(6):2271 Food packs means you because on the basis of the scientific of hunger wont be starving once evidence assessed, this claimed effect you're in ketosis your for this food has not been physical hunger is substantiated. suppressed. With such formula food, clients experience little, if any hunger as after around 3-4 days the body goes into a state of ketosis.

Non-authorised

197

Non-authorised

3180

Non-authorised

1411

Generated on: 28/01/2014 09:37 AM

Page 724

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Berry seed oils (supercritical carbon dioxide extract)

Art.13(1) Nutrim Oat Bran

The essential fatty acids Non-compliance with the Regulation Cardiovascular health 2011;9(6):2228 in berry seed oils because on the basis of the scientific balance fatty acid evidence assessed, this claimed effect metabolism in the body. for this food is not sufficiently defined Berry seed oils support to be able to be assessed and the the health of the claim could not therefore be cardiovascular system. substantiated. The inclusion of 3 Non-compliance with the Regulation Maintenance or 2010;8(2):1482 grams oat beta glucan because on the basis of the scientific achievement of normal soluble fiber per day evidence assessed, this claimed effect blood glucose from Nutrim Oat Bran, for this food has not been concentrations as part of a diet low in substantiated. saturated fat and a healthy lifestyle, can help maintain healthy blood glucose levels. Oat beta glucan soluble fiber from Nutrim Oat Bran, as part of a diet low in saturated fat and a healthy lifestyle, can help maintain healthy blood glucose levels.

Non-authorised

569

Non-authorised

802

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) BarleyTrim Barley Bran The inclusion of 3 Non-compliance with the Regulation Maintenance or 2010;8(2):1482 grams of barley beta because on the basis of the scientific achievement of normal glucan soluble fiber evidence assessed, this claimed effect blood glucose from BarleyTrim for this food has not been concentrations Barley Bran, as a part of substantiated. a diet low in saturated fat and a healthy lifestyle, can help maintain healthy blood glucose levels Barley beta glucan soluble fiber from BarleyTrim helps maintain healthy blood cholesterol levels. Art.13(1) Cheese-like product The products fat Non-compliance with the Regulation maintenance of normal 2011;9(4):2068 containing rapeseed oil composition complies because on the basis of the scientific blood LDL-cholesterol /MUFA, PUFA with nutritional evidence assessed, this claimed effect concentrations recommendations and for this food has not been helps to control substantiated. cholesterol.

Non-authorised

756

Non-authorised

581

Generated on: 28/01/2014 09:37 AM

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Glucose and fructose

Art.13(1) Single and oligomeric flavan-3-ols.

Art.13(1) Single and oligomeric flavan-3-ols.

The ratio of 2:1 of Non-compliance with the Regulation increase in endurance 2011;9(6):2247 glucose and fructose because on the basis of the scientific performance sources help deliver evidence assessed, this claimed effect more energy to for this food has not been muscles. substantiated. Delivers even longer lasting energy. Faster energy delivery compared with glucose. Delivers more sustained energy to muscles. Enahnced carbohydrate delivery, availability and utilisation. This Food Component Non-compliance with the Regulation not validated 2010;8(10):1737 has significant because on the basis of the scientific antioxidant activity and evidence assessed, this food is not helps the skin maintain sufficiently characterised for a normal functions under scientific assessment of this claimed UV-induced stress effect and the claim could not therefore be substantiated. This Food Component Non-compliance with the Regulation not validated 2010;8(10):1737 keeps blood vessels because on the basis of the scientific healthy by helping them evidence assessed, this food is not maintain normal sufficiently characterised for a structure, elasticity and scientific assessment of this claimed permeability, especially effect and the claim could not therefore in legs and eyes. be substantiated.

Non-authorised

472

Non-authorised

1965

Non-authorised

1964

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Single and oligomeric flavan-3-ols.

This Food Component scavenges free radicals and has significant antioxidant activity.

Art.13(1) The food component is a mix of linoleic acid and gamma-linolenic acid.

Art.13(1) AMORPHOPHALLUS KONJAC KOCH

Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. This fatty acids mix * Non-compliance with the Regulation reduction of ocular 2011;9(6):2230 improves tear quantity because on the basis of the scientific dryness This fatty acids mix * evidence assessed, this claimed effect contributes to ocular for this food has not been comfort/visual comfort substantiated. This fatty acids mix * improves lachrymal functions This fatty acids mix * decreases ocular dryness * linoleic acid and gamma-linolenic acid Through balanced diets Non-compliance with the Regulation maintenance of normal 2010;8(10):1798 helps the control of because on the basis of the scientific (fasting) blood lipidic metabolism evidence assessed, this claimed effect concentrations of (cholesterol and for this food has not been triglycerides triglycerides). Natural substantiated. source maintaining the physiological fats balance in blood.

Non-authorised

1966

Non-authorised

4274

Non-authorised

3217

Generated on: 28/01/2014 09:37 AM

Page 728

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Amino acids

To assist in the repair Non-compliance with the Regulation not validated and recovery of muscle because on the basis of the scientific tissue following evidence assessed, this food is not strenuous exercise. sufficiently characterised for a Helps muscle scientific assessment of this claimed maintenance and effect and the claim could not therefore recovery following be substantiated. exercise. Art.13(1) Omega-3 fatty acids (incl. To protect the Non-compliance with the Regulation maintenance of normal DHA) cardiovascular system/It because on the basis of the scientific blood LDL-cholesterol promotes heart health evidence assessed, this claimed effect concentrations To support the fat for this food has not been metabolism substantiated. Art.13(1) Glutamine To support the body's Non-compliance with the Regulation immune defense system. To because on the basis of the scientific function/immune support immnue evidence assessed, this claimed effect system system. To enhance for this food is not sufficiently defined organism resistance. to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lycopenes from tomato Tomato is as almost Non-compliance with the Regulation protection of DNA, pulp and sauces unique as a source of a because on the basis of the scientific proteins and lipids from specific carotene evidence assessed, this claimed effect oxidative damage named: Lycopene; for this food has not been Therefore use it always substantiated. is any conditions for its nutritional qualities

2011;9(6):2244

Non-authorised

1711

2010;8(10):1796

Non-authorised

538

2010;8(10):1799

Non-authorised

433

2011;9(4):2031

Non-authorised

1899

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Page 729

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Tomato juice

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Gele Royale Tonifie et revitalise Non-compliance with the Regulation not validated l'organisme because on the basis of the scientific Entretien l'nergie et le evidence assessed, this food is not tonus sufficiently characterised for a A utiliser en cas de scientific assessment of this claimed fatigue passagre effect and the claim could not therefore Soutient le systme de be substantiated. dfense Art.13(1) Polyphenols derived from Total red wine Non-compliance with the Regulation not validated red wine polyphenols help because on the basis of the scientific vascular functions that evidence assessed, this food is not contribute to a healthy sufficiently characterised for a cardiovascular system. scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Activated charcoal Traditionally used to Non-compliance with the Regulation reduction of bloating contribute to good because on the basis of the scientific digestive comfort evidence assessed, this claimed effect Usually known for its for this food has not been contribution to good substantiated. digestive

Tomato juice has a positive Influence on blood sugar level

2011;9(6):2243

Non-authorised

1202

2011;9(4):2083

Non-authorised

1326

2011;9(4):2082

Non-authorised

1641, 1642

2011;9(4):2049

Non-authorised

1938

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Armorica rusticana common name : Horseradish

Traditionally used to Non-compliance with the Regulation improvement of diuretic 2009;7(9):1282 enhance the renal because on the basis of the scientific function elimination of water. evidence assessed, this claimed effect Traditionally used to for this food has not been facilitate the elimination substantiated. functions of the organism. Used to enhance the renal elimination of water. Used to facilitate the elimination functions of the organism. Used for the drainage of the organism. Diuretic effect. Stimulates the elimination function of the organism. Contributes to the functionary of the urinary tract. Art.13(1) Probiotics as contained in Travla probiotic Non-compliance with the Regulation not validated 2009;7(9):1247 the probiotic formula maintains digestive because on the basis of the scientific Travla: Saccharomyces health and immunity evidence assessed, this food is not boulardii, Lactobacillus when eating and sufficiently characterised for a acidophilus (CNCM Idrinking abroad. scientific assessment of this claimed 1722), Lactobacillus effect and the claim could not therefore rhamnosus (CNCM I-1720),Travla probiotic helps be substantiated. Bifidobacterium longum prevent digestive upsets (CNCM I-3470) caused by pathogenic organisms when travelling abroad

Non-authorised

2719

Non-authorised

928

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Page 731

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Tyrosine

Art.13(1) Whole grain, whole grain flour

Art.13(1) Whole grain, whole grain flour

Tyrosine helps maintain Non-compliance with the Regulation increased attention mental focus and because on the basis of the scientific performance during evidence assessed, this claimed effect exposure to for this food has not been environmentally substantiated. adverse conditions Tyrosine limits mental fatigue during exposure to environmentally adverse conditions. Tisteratoodete Non-compliance with the Regulation not validated tarbimine reguleerib because on the basis of the scientific vere kolesteroolitaset. evidence assessed, this food is not Clarifications provided sufficiently characterised for a Consuming whole grain scientific assessment of this claimed products regulates effect and the claim could not therefore blood cholesterol level. be substantiated. Tisteratoodete Non-compliance with the Regulation not validated tarbimine soodustab because on the basis of the scientific seedimist.Tisteratoode evidence assessed, this food is not te tarbimine aitab sufficiently characterised for a soodustada seedimist. scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2270

Non-authorised

440

2010;8(10):1766

Non-authorised

1268

2010;8(10):1766

Non-authorised

1271

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whole grain, whole grain flour

Art.13(1) Whole grain, whole grain flour

Tisteratoodete tarbimine suurendab kllastustunnet ehk tiskhutunnet. Tisteratoodete tarbimine pikendab kllastustunde ehk tiskhutunde silimist. Clarifications provided Consuming whole grain products increases satiety. Consuming whole grain products prolongs the feeling of satiety. Tisteratooteid iseloomustab madal glkeemiline indeks. Clarifications provided Whole grain products are characterised by low glycaemic index

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1766

Non-authorised

1269

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(10):1766

Non-authorised

1270

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Armorica rusticana common name : Horseradish

Art.13(1) SOIA ISOFLAVONI

Art.13(1) Brewer's yeast (Saccharomyces cerevisiae)

Used to enhance the Non-compliance with the Regulation improvement of diuretic 2009;7(9):1282 renal elimination of because on the basis of the scientific function water. Used to facilitate evidence assessed, this claimed effect the elimination functions for this food has not been of the organism. Used substantiated. for the drainage of the organism. Stimulates the elimination function of the organism. Contributes to the functionary of the urinary tract. Useful for normal Non-compliance with the Regulation Useful for normal 2011;9(7):2264 prostate function. because on the basis of the scientific prostate function. evidence assessed, this claimed effect attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods. Useful in case of fragile Non-compliance with the Regulation Maintenance of normal 2011;9(6):2228 nails. because on the basis of the scientific structure and Helps to support the evidence assessed, this claimed effect appearance of hair and hair's vitality. has not been linked to a function of the nails Helps to Improve the body, as required by Article 13 of the structure and Regulation. appearance of hair and nails. Helps to support hair and nails health.

Non-authorised

2224

Non-authorised

3588

Non-authorised 1233 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Radis noir: Raphanus niger Usually recognized for (Black radish) helping digestion. Usually recognized for helping transit Art.13(1) Lecithine de soja: soy lecithin Usually recognized to act in case of hypercholesterolemia; Usually recognized to help rate cholesterol stabilization.

Non-compliance with the Regulation changes in bowel 2011;9(6):2246 because on the basis of the scientific function evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation maintenance of normal 2010;8(10):1741 because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

2752

Non-authorised

1961

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Spermidina 3HCL[4]

Art.13(1) Very low calorie diet (VLCD) Programme

Utile per il trofismo Non-compliance with the Regulation contribution to normal (nutriemento e because on the basis of the scientific hair growth benessere) dei capelli, evidence assessed, this claimed effect nelle varie fasi del loro for this food has not been ciclo di vita). E di substantiated. stimolo per la proliferazione delle cellule del bulbo pilifero, favorendo la fase di crescita dei capelli (anagen) e contrastandone la caduta. Clarification provided Useful for the hair health and nutrition during life cycle. Stimulates the cell proliferation at hair bulb improving the growth phase (anagen) against hair loss. VLCD/low carbohydrate Non-compliance with the Regulation not validated diets helps to the because on the basis of the scientific maintenance of normal evidence assessed, this food is not blood lipid profile sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2265

Non-authorised

1705

2011;9(6):2271

Non-authorised

1421

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) VitaGranate VitaGranate Pomegranate Extract 40% Pomegranate Extract is Ellagic Acid an excellent source of pomegranate polyphenols, compounds that have been associated with the maintenance of cardiovascular health. Art.13(1) Vitamin A Vitamin A aids healthy bone and teeth growth.

Non-compliance with the Regulation maintenance of normal 2010;8(10):1750 because on the basis of the scientific blood cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

2167

Art.13(1) Vitamin A

Vitamin A aids healthy bone and teeth growth.

Art.13(1) Vitamin A

Vitamin A protects against free-radicalinduced muscle damage. Vitamin C, E, A, D, B6, B12 folic acid, Selenium, Zinc, Copper and Iron are important for the immune system/natural defences

Art.13(1) Vitamin E

Non-compliance with the Regulation maintenance of bone because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation maintenance of teeth because on the basis of the scientific evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation protection of DNA, because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. Non-compliance with the Regulation maintenance of the because on the basis of the scientific normal function of the evidence assessed, this claimed effect immune system for this food has not been substantiated.

2009;7(9):1221

Non-authorised

13

2009;7(9):1221

Non-authorised

13

2009;7(9):1261

Non-authorised

209

2010;8(10):1816

Non-authorised

163

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Vitamin D

Art.13(1) vit D3

Art.13(1) Vitamin E

Art.13(1) Vitamin K1 + K2

Vitamin D is needed for Non-compliance with the Regulation thyroid function the normal / proper because on the basis of the scientific function of the thyroid. evidence assessed, this claimed effect Vitamin D is needed for for this food has not been the proper regulation of substantiated. blood calcium levels. Vitamin D3 has long Non-compliance with the Regulation Normal cardiovascular been known to aid in because on the basis of the scientific function calcium absorption, but evidence assessed, this claimed effect new research shows for this food has not been that D3 also plays a role substantiated. in cardiovascular function and supports healthy inflammatory response Vitamin D3 has long been known to aid in calcium absorption, but new resea Vitamin E is an Non-compliance with the Regulation maintenance of the antioxidant that protects because on the basis of the scientific normal function of the the body's cells. evidence assessed, this claimed effect immune system for this food has not been substantiated. Vitamin K1 and K2 Non-compliance with the Regulation function of the heart supports a healthy heart because on the basis of the scientific and blood vessels Vitamin K1 and K2 evidence assessed, the evidence stimulates blood provided is insufficient to substantiate clotting. this claimed effect for this food.

2009;7(9):1227

Non-authorised

156

2010;8(2):1468

Non-authorised

159

2010;8(10):1816

Non-authorised

161

2009;7(9):1228

Non-authorised

124

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Q10 with Sea Buckthorn Oil, Q 10, Hippophae oleum, Q 10 , Hippophae oleum

Art.13(1) All vitamins and minerals

Vitaminising / Has antioxidant properties and helps protect you from radicals which cause cell damage / Physical endurance, mental performance / Helps to protect heart health / Supports digestive and hepatic health/ Immune system health / Contributes to the resistance against stress. Vitamins and minerals are essential to sutstain physical and mental vitality while ageing

Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

4611

Non-compliance with the Regulation multivitamin because on the basis of the scientific supplementation to evidence assessed, this claimed effect sustain vitality while for this food is not sufficiently defined aging and to be able to be assessed and the development claim could not therefore be substantiated.

2011;9(4):2077

Non-authorised

Generated on: 28/01/2014 09:37 AM

Page 739

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) WGP beta-glucan;(WGP (1,3)-b-D-glucan);(from Saccharomy-ces cerevisiae)

Art.13(1) Walnuts

WGP beta-glucan Non-compliance with the Regulation maintenance of the 2011;9(6):2248 contributes to the because on the basis of the scientific upper respiratory tract normal function of the evidence assessed, this claimed effect defence against immune system. WGP for this food has not been pathogens by beta-glucan naturally substantiated. maintaining immune contributes to adequate defences immune responses. The daily dietary supplementation with WGP beta-glucan promotes the normal function of the immune system. WPG betaglucan enhances the production and activity of the macrophages and neutrophiles. Thus, it plays an important role in the adequate function of the immune system. WGP beta-glucan contributes to maitain the normal function of upper respiratoy tract. Walnuts contain a well- Non-compliance with the Regulation maintenance of normal 2011;9(4):2074 balanced ratio of because on the basis of the scientific blood LDL-cholesterol unsaturated fatty acids evidence assessed, this claimed effect concentrations which helps maintaining for this food has not been a healthy heart. substantiated.

Non-authorised

1910

Non-authorised

1158

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Walnuts

Walnuts support cardiovascular health.

Art.13(1) Water- soluble dietary fibre Water-soluble dietary fibres as a part of the healthy diet support the maintenance of normal blood cholesterol level.

Art.13(1) Calcium

Water-soluble vitamins, calcium, magnesium and zinc are essential for mental function and performance In situations of inadequate micronutrient status, supplementation with water-soluble vitamins, minerals and zinc can sustain mental performance (e.g. concentration, learning, memory, reasoning).

Non-compliance with the Regulation maintenance of normal 2011;9(4):2074 because on the basis of the scientific blood LDL-cholesterol evidence assessed, this claimed effect concentrations for this food has not been substantiated. Non-compliance with the Regulation maintenance of normal 2009;7(9):1255 because on the basis of the scientific blood cholesterol evidence assessed, this food is not concentrations sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation contribution to normal 2010;8(10):1725 because on the basis of the scientific psychological functions evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

1156

Non-authorised

811

Non-authorised

233

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Aspartame sucrose substitute

Art.13(1) Wheat Dextrin

Weight control Non-compliance with the Regulation contribution to the 2011;9(6):2229 /management is helped because on the basis of the scientific maintenance or by using foods and evidence assessed, this claimed effect achievement of a beverages sweetened for this food has not been normal body weight with Aspartame in place substantiated. of foods and beverages sweetened with sugar. Wheat dextrin helps to Non-compliance with the Regulation increase in magnesium 2010;8(10):1761 improve the absorption because on the basis of the scientific and/or calcium of calcium and evidence assessed, this claimed effect retention magnesium; two for this food has not been minerals that are substantiated. essential for healthy muscles and bones. Wheat dextrin improves magnesium and calcium absorption and retention. Wheat dextrin helps increase the absorption and retention of certain vital nutrients and promotes overall good health.

Non-authorised

1444

Non-authorised

846, 3097

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Wheat dextrin is Non-compliance with the Regulation decreasing potentially 2010;8(10):1761 fermented in the gut because on the basis of the scientific pathogenic gastroleading to the evidence assessed, this claimed effect intestinal production of the for this food has not been microorganisms beneficial SCFA. substantiated. Wheat dextrin helps promote colon health. Wheat dextrin nourishes the digestive tract, where 70% of immune function occurs. Wheat dextrin stimulates the microflora to restore and maintain digestive system's healthy balance. Wheat dextrin stimulates the microflora (prebiotic effect).

Non-authorised

1681

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Wheat Dextrin

Wheat dextrin is Non-compliance with the Regulation short chain fatty acid fermented in the gut because on the basis of the scientific (SCFA) production in leading to the evidence assessed, this claimed effect the bowel production of the for this food is not a beneficial beneficial SCFA. physiological effect as required by the Wheat dextrin helps Regulation. promote colon health. Wheat dextrin nourishes the digestive tract, where 70% of immune function occurs. Wheat dextrin stimulates the microflora to restore and maintain digestive system's healthy balance. Wheat dextrin stimulates the microflora (prebiotic effect). Art.13(1) Vitamins, minerals, lysine When a child is Non-compliance with the Regulation not validated and/or arginine and/or recovering from illness, because on the basis of the scientific taurine or has a loss of evidence assessed, this food is not (Pharmaton Kiddi) appetite, Pharmaton sufficiently characterised for a Kiddi provides important scientific assessment of this claimed vitamins, minerals. effect and the claim could not therefore These are important for be substantiated. developing and supporting proper immune system functions.

2010;8(10):1761

Non-authorised

1681

2011;9(4):2083

Non-authorised

1676

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Page 744

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Standardised Potato Extract

Art.13(1) Standardised Potato Extract

When taken before a meal, supports the body's natural satiety response naturally supports feelings of fullness after a meal helps manage appetite and hunger promotes feelings of fullness and satiety satiety aid helps to feel full sooner When taken before a meal, supports the body's natural satiety response naturally supports feelings of fullness after a meal helps manage appetite and hunger promotes feelings of fullness and satiety satiety aid helps to feel full sooner

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2246

Non-authorised

1656

Non-compliance with the Regulation increase in satiety 2011;9(6):2246 because on the basis of the scientific leading to a reduction in evidence assessed, this claimed effect energy intake for this food has not been substantiated.

Non-authorised

1656

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Whey protein enhances Non-compliance with the Regulation not validated mood and mental well- because on the basis of the scientific being evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Whey Protein Whey protein essential Non-compliance with the Regulation growth or maintenance amino acids aid muscle because on the basis of the scientific of muscle mass maintenance and evidence assessed, this claimed effect growth for this food has not been substantiated. Art.13(1) Whey Protein Whey protein helps Non-compliance with the Regulation not validated athletes maintain a because on the basis of the scientific healthy immune system evidence assessed, this food is not by increasing the levels sufficiently characterised for a of glutathione in the scientific assessment of this claimed body. Glutathione is an effect and the claim could not therefore antioxidant required for be substantiated. a healthy immune system and exercise and resistance training may reduce glutathione levels. Art.13(1) Whey protein Hydrolysate Whey protein Non-compliance with the Regulation faster recovery from hydrolysate enhances because on the basis of the scientific muscle fatigue after muscle recovery. evidence assessed, this claimed effect exercise Glutamine-rich whey for this food has not been protein enhances substantiated. muscle recovery.

2011;9(6):2243

Non-authorised

432

2010;8(10):1818

Non-authorised

427

2011;9(6):2243

Non-authorised

424

2010;8(10):1818

Non-authorised

431

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Art.13(1) Whey Protein

Whey protein improves Non-compliance with the Regulation not validated cognitive performance because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Whey protein provides Non-compliance with the Regulation faster recovery from fast delivery of muscle- because on the basis of the scientific muscle fatigue after building amino acids evidence assessed, this claimed effect exercise after training to aid for this food has not been recovery and support substantiated. muscle growth. Whey protein is a soluble, easy to digest protein and is efficiently absorbed into the body.Its often referred to as a fast protein for its ability to quickly provide nourishment to muscles.

2011;9(6):2243

Non-authorised

430

2010;8(10):1818

Non-authorised

423

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Whey Protein

Art.13(1) Pomegranate Juice phenolic compounds (anthocyanins, tannines, ellagic acid) Art.13(1) Zinc

Whey protein provides fast delivery of musclebuilding amino acids after training to aid recovery and support muscle growth. Whey protein is a soluble, easy to digest protein and is efficiently absorbed into the body.Its often referred to as a fast protein for its ability to quickly provide nourishment to muscles. With powerful antioxidant properties.

Non-compliance with the Regulation growth or maintenance 2010;8(10):1818 because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

423

Non-compliance with the Regulation protection of lipids from 2010;8(10):1750 because on the basis of the scientific oxidative damage evidence assessed, this claimed effect for this food has not been substantiated. Without enough zinc in Non-compliance with the Regulation muscle function 2009;7(9):1229 your diet, muscular because on the basis of the scientific performance will be evidence assessed, this claimed effect impaired for this food has not been substantiated.

Non-authorised

1319

Non-authorised

299

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) xanthohumol

Xanthohumol protects body cells from harmful free radicals which damage cells, protects them from oxidation induced cell stress and reinforces cell protection. Art.13(1) Xylitol Xylitol helps reduce plaque formation Xylitol helps neutralize plaque acids Xylitol helps protect teeth against the formation of plaque Art.13(1) Xylitol-sweetened chewing Xylitol is good for the gum health of ears. Maintains good health of the ears.

Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated.

Non-authorised

3168, 3176

Non-compliance with the Regulation Reduction of dental because on the basis of the scientific plaque evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2266

Non-authorised

485

Non-compliance with the Regulation Defence against 2011;9(6):2266 because on the basis of the scientific pathogens in the middle evidence assessed, the evidence ear provided is insufficient to substantiate this claimed effect for this food.

Non-authorised

561, 1180

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Brassicaceae (Cruciferae) (nazwa powszechnie stosowana: rodzina ro?lin kapustowatych (krzy?owych))

Zawiera antyoksydanty Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 (przeciwutleniacze)/ because on the basis of the scientific proteins and lipids from ?rd?o antyoksydantw evidence assessed, this claimed effect oxidative damage (przeciwutleniaczy)/ z for this food has not been antyoksydantami substantiated. (przeciwutleniaczami)/ szczeglnie bogate w sk?adniki chroni?ce komrki oraz DNA przed uszkodzeniem oksydacyjnym/ szczeglnie bogate w sk?adniki pomagaj?ce w eliminowaniu substancji niekorzystnych z organizmu Clarification provided Contains antioxidants/ source of antioxidants/ with antioxidants/ Are particularly rich in protective compounds that protect cells and DNA from oxidative damage/ are particularly rich in compounds that help our body to eliminate toxic substances.

Non-authorised

3276

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Zinc

Art.13(1) Zinc

Art.13(1) Zinc

Zinc contributes to a Non-compliance with the Regulation function of the heart healthy cardiovascular because on the basis of the scientific and blood vessels system evidence assessed, this claimed effect for this food has not been substantiated. Zinc for a healthy Non-compliance with the Regulation prostate function prostate because on the basis of the scientific Zinc helps to maintain a evidence assessed, this claimed effect healthy prostate for this food has not been substantiated. Zinc promotes joint Non-compliance with the Regulation maintenance of joints health because on the basis of the scientific Zinc helps support the evidence assessed, this claimed effect function of the joints for this food has not been substantiated.

2009;7(9):1229

Non-authorised

306

2009;7(9):1229

Non-authorised

307

2009;7(9):1229

Non-authorised

305

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Papayafruchtfleisch Zur natrlichen Non-compliance with the Regulation reduction of gastro(CARICOL)ballaststoffreiUntersttzung und because on the basis of the scientific intestinal discomfort che Fruchtzubereitung, Regulierung der evidence assessed, this claimed effect hergestellt aus dem Verdauung, for this food has not been Fruchtfleisch baumgereifter insbesondere bei der substantiated. Papayafrchte nach einem Neigung zu Blhungen, international patentierten Sodbrennen, hartem Verfahren oder ungeformtem (PCT/IB2003/005476).C Stuhl. ARICOL ist eine Verbessert die international geschtzte Verdauung. Marke (820 Clarification provided Naturally supports and regulates the digestive system, especially relating to excessive flatulence or gas, or a tendency towards loose stool, constipation or heart burn. Improves the digestion. Art.13(1) Nsse - Erdnsse, [In German:] Der Non-compliance with the Regulation not validated Haselnsse, Pekansse, Verzehr von 30g because on the basis of the scientific Walnsse und Pistazien,; Nssen pro Tag im evidence assessed, this food is not KEINE Paransse, Rahmen einer sufficiently characterised for a Macadamiansse und ausgewogenen scientific assessment of this claimed Cashewkerne Ernhrung kann zum effect and the claim could not therefore Gewichtsverlust und zur be substantiated. Erhaltung des Gewichts beitragen.

2011;9(6):2248

Non-authorised

3080

2011;9(4):2032

Non-authorised

1407

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Sauerkraut Saft (milchsauer vergorener Weikohl (Brassica oleracea var. capitata)

[In German:] Non-compliance with the Regulation changes in bowel 2011;9(6):2246 Sauerkrautsaft regt die because on the basis of the scientific function Verdauung an. evidence assessed, this claimed effect Clarification provided for this food has not been Helps to support the substantiated. digestion / contributes to the normal function of intestinal tract / functioning of the stomach / sauerkaut juice activate the eupepsia. Art.13(1) Stutenmilch, naturbelassen [In German:] Non-compliance with the Regulation Increasing numbers of 2011;9(6):2228 Stutenmilch kann die because on the basis of the scientific gastro-intestinal Anzahl an evidence assessed, this claimed effect microorganisms Bifidusbakterien im for this food is not a beneficial Darm erhhen. physiological effect as required by the Clarification provided Regulation. Mares milk is able to increase the number of intestinal bifidus bacteria Art.13(1) Stutenmilch, naturbelassen [In German:] Non-compliance with the Regulation Immune system 2011;9(6):2228 Stutenmilch kann die because on the basis of the scientific Anzahl an evidence assessed, this claimed effect Bifidusbakterien im for this food is not sufficiently defined Darm erhhen. to be able to be assessed and the Clarification provided claim could not therefore be Mares milk is able to substantiated. increase the number of intestinal bifidus bacteria

Non-authorised

1409

Non-authorised

1399

Non-authorised

1399

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) natrliches Mineralwasser [In German:] trgt zur Non-compliance with the Regulation Maintenance of sichtbaren because on the basis of the scientific structure and elasticity Verbesserung der evidence assessed, this claimed effect of the skin Hautoberflchenstruktur has not been linked to a function of the bei. body, as required by Article 13 of the Clarification provided Regulation. Contributes to visible improvement of the skin surface structure. Art.13(1) Mineralwasser/ [In German:] zur Non-compliance with the Regulation increase in appetite Natriumchlorid Anregung des Appetits. because on the basis of the scientific after unintentional Clarification provided evidence assessed, this claimed effect weight loss leading to To stimulate the for this food has not been an increase in energy appetite. substantiated. intake Art.13(1) Vitamin E [In German] Wichtig fr Non-compliance with the Regulation maintenance of normal Blutflieeigenschaften. because on the basis of the scientific blood circulation Clarification provided evidence assessed, this claimed effect Important for blood flow for this food has not been parameters. substantiated. Art.13(1) Lactobacillus LA-5 [In german : ] Non-compliance with the Regulation not validated Begnstigt die because on the basis of the scientific Darmflora evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(6):2228

Non-authorised 1406 (expiry of transitional period 02/01/2014)

2011;9(6):2246

Non-authorised

411

2010;8(10):1816

Non-authorised

216

2009;7(9):1247

Non-authorised

1098

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Calcium

Art.13(1) Gemse / Rote Beete / Kalium

Art.13(1) Kalium

[In german : ] Calcium ist wichtig zur Untersttzung des Stoffwechsels Clarification provided Calcium supports the regulation of the acid base balance [In german : ] Kalium ist an der Aktivierung einiger Enzyme und dem Aufbau von krpereigenem Eiwei beteiligt. Clarification provided potassium is involved in activation processes of several enzymes as well as in formation of protein produced naturally in the body [In german : ] Kalium ist wichtig zur Untersttzung des Stoffwechsels Clarification provided potassium supports the regulation of the acid base balance (within several metabolic processes)

Non-compliance with the Regulation maintenance of normal 2011;9(6):2201 because on the basis of the scientific acid-base balance evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

400

Non-compliance with the Regulation contribution to normal because on the basis of the scientific protein metabolism evidence assessed, this claimed effect for this food has not been substantiated.

2011;9(6):2247

Non-authorised

406

Non-compliance with the Regulation maintenance of normal 2011;9(6):2201 because on the basis of the scientific acid-base balance evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

407

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Niacin

Non-compliance with the Regulation Maintenance of normal 2010;8(10):1757 because on the basis of the scientific blood flow evidence assessed, the proposed conditions of use would encourage excess consumption of this food, which is contrary to the criteria laid down in the Regulation. Art.13(1) Essentielle Fettsuren [In german : ] fr einen Non-compliance with the Regulation not validated 2011;9(4):2032 (Omega 6 und Omega 3) inausbalancierten because on the basis of the scientific Nul Fettstoffwechsel. evidence assessed, this food is not Clarification provided sufficiently characterised for a Equilibrated scientific assessment of this claimed lipometabolism: effect and the claim could not therefore Omega 3 fatty acids be substantiated. help to control / regulate blood lipids / lipid profile contributing to a healthy vascular system. Art.13(1) Mineralwasser/Natrium[In german : ] gut fr Non-compliance with the Regulation maintenance of normal 2011;9(6):2262 Hydrogencarbonat den Blutdruck because on the basis of the scientific blood pressure Clarification provided evidence assessed, this claimed effect supports regulation of for this food has not been blood pressure substantiated. Art.13(1) Standardisierter [In german : ] hilft Ihnen, Non-compliance with the Regulation contribution to the 2011;9(6):2246 Kartoffelextrakt kontrolliert und nicht because on the basis of the scientific maintenance or zwischen den evidence assessed, this claimed effect achievement of a Mahlzeiten zu essen for this food has not been normal body weight Clarification provided substantiated. helps not to eat between meals

[In german : ] Wichtig fr den Blutfluss der Gefe Clarification provided Important for vascular blood flow

Non-authorised 211 (expiry of transitional period 02/01/2014)

Non-authorised

741

Non-authorised

1404

Non-authorised

2870

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Standardisierter Kartoffelextrakt

[In german : ] hilft Ihnen, Non-compliance with the Regulation increase in satiety 2011;9(6):2246 kontrolliert und nicht because on the basis of the scientific leading to a reduction in zwischen den evidence assessed, this claimed effect energy intake Mahlzeiten zu essen for this food has not been Clarification provided substantiated. helps not to eat between meals Art.13(1) Mineralwasser/ [In german : ] ist Non-compliance with the Regulation maintenance of normal 2011;9(7):2301 Hydrogencarbonat zusammen mit Calcium because on the basis of the scientific bone (Bicarbonat) fr eine gute evidence assessed, this claimed effect Knochendichte for this food has not been notwendig substantiated. Clarification provided: Hydrogencarbonate from mineral water cares together with calcium for adequate bone density significantly Art.13(1) Mineralwasser/Hydrogenca [In german : ] kann die Non-compliance with the Regulation increase in endurance 2011;9(6):2247 rbonat Muskelermdung beim because on the basis of the scientific performance (Bicarbonat) Ausdauersport evidence assessed, this claimed effect verzgern for this food has not been Clarification provided substantiated. can delay tiring of muscles in endurance sports

Non-authorised

2870

Non-authorised

1402

Non-authorised

1403

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Mineralwasser/ Kohlensure

Non-compliance with the Regulation Digestive function because on the basis of the scientific evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Arginin [In german : ] strkt die Non-compliance with the Regulation Function of the Darmmucosa. because on the basis of the scientific intestinal tract Clarification provided evidence assessed, this claimed effect Strengthens the gut for this food is not sufficiently defined mucosa. to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Mineralwasser/ Kieselsure[In german : ] Non-compliance with the Regulation contribution to normal (Silizium) strkt/festigt das because on the basis of the scientific formation of collagen Bindegewebe evidence assessed, this claimed effect and connective tissue Clarification provided for this food has not been strengthens/stabilizes substantiated. the connective tissue Art.13(1) Mineralwasser/ Kieselsure[In german : ] Non-compliance with the Regulation maintenance of normal (Silizium) strkt/festigt das because on the basis of the scientific joints Bindegewebe evidence assessed, this claimed effect Clarification provided for this food has not been strengthens/stabilizes substantiated. the connective tissue

[In german : ] regt die Verdauung an Clarification provided stimulates digestion

2011;9(6):2228

Non-authorised

1401

2011;9(4):2051

Non-authorised

740

2011;9(6):2259

Non-authorised

1405

2011;9(6):2259

Non-authorised

1405

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bioaktive Oligosaccharide, [In german: ] Bioaktive wie z. B. glykosylierte Oligosaccharide Phenylethanoide gehren zu den strksten Radikalfngern Antioxidantien aus der Natur. Bioaktive Oligosaccharide fangen freie Radikale ab. Clarification provided Bioactive oligosaccharides are among the strongest natural radical scavenger/ natural andioxidatiants so that they can trap radicals effectively Art.13(1) Bioaktive Oligosaccharide, [In german: ] Bioaktive wie z. B. glykosylierte Oligosaccharide zur Phenylethanoide natrlichen / aktiven Untersttzung / Optimierung der Muskelkraft. Clarification provided Bioactive oligosaccharides optimise mucular strength.

Non-compliance with the Regulation antioxidant activity, 2010;8(10):1752 because on the basis of the scientific antioxidant content, and evidence assessed, this claimed effect antioxidant properties for this food is not a beneficial physiological effect as required by the Regulation.

Non-authorised

857

Non-compliance with the Regulation growth or maintenance 2011;9(6):2247 because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

858

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Mineralwasser/ Calcium

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Art.13(1)

Non-compliance with the Regulation maintenance of normal 2010;8(10):1725 because on the basis of the scientific hair and nails evidence assessed, this claimed effect for this food has not been substantiated. Cherries (Prunus cerasus), [Tart/sour] cherries help Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 including Montmorency, support a healthy heart because on the basis of the scientific proteins and lipids from Balaton or other sour/tart evidence assessed, this claimed effect oxidative damage cherry varieties for this food has not been substantiated. Cherries (Prunus cerasus, [Tart/sour] cherries help Non-compliance with the Regulation contribution to normal 2011;9(6):2248 P. domestica), including support healthy brain / because on the basis of the scientific cognitive function Montmorency, Balaton or mental function. evidence assessed, this claimed effect other sour/tart cherry for this food has not been varieties substantiated. Cherries (Prunus cerasus), [Tart/sour] cherries help Non-compliance with the Regulation Maintenance of joints 2010;8(2):1493 including Montmorency, support healthy joints because on the basis of the scientific Balaton or other sour/tart evidence assessed, this claimed effect cherry varieties for this food has not been substantiated. Cherries (Prunus cerasus), [Tart/sour] cherries Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 including Montmorency, provide a rich source of because on the basis of the scientific content, and antioxidant Balaton or other sour/tart antioxidants. evidence assessed, this claimed effect properties cherry varieties for this food is not a beneficial physiological effect as required by the Regulation. Food reduced/ low/ free of [x] helps maintain your Non-compliance with the Regulation not validated 2011;9(6):2244 energy body weight (as part of because on the basis of the scientific a calorie controlled evidence assessed, this food is not diet). sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

[In german:] krftigt die Ngel Clarification provided strengthens the nails.

Non-authorised

399

Non-authorised

2023

Non-authorised

2024

Non-authorised

2022

Non-authorised

2021

Non-authorised

1146

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) a-Lactalbumin

Non-compliance with the Regulation not validated 2011;9(6):2243 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) AHCC - Active Hexose activates immune Non-compliance with the Regulation Stimulation of 2011;9(4):2061 Correlated Compound system, exert potential because on the basis of the scientific immunological effects on the immune evidence assessed, this claimed effect responses system - stimulating for this food is not a beneficial immunity physiological effect as required by the Regulation. Art.13(1) Pleurotus ostreatus (oyster antioxidants can protect Non-compliance with the Regulation Protection of DNA, 2010;8(2):1489 mushroom) you from radicals which because on the basis of the scientific proteins and lipids from cause cell damage evidence assessed, this claimed effect oxidative damage antioxidants can protect for this food has not been your cells and tissues substantiated. from oxidative damage; antioxidants contribute to the total antioxida Art.13(1) Glutathion antioxydant, contributes Non-compliance with the Regulation Antioxidant, antioxidant 2010;8(2):1489 to the antioxidant because on the basis of the scientific content, and antioxidant defense system, evidence assessed, this claimed effect properties contributes to the for this food is not a beneficial body?s immune physiological effect as required by the response Regulation.

a-Lactalbumin increases cognitive function

Non-authorised

1433

Non-authorised

3139

Non-authorised

3520

Non-authorised

1971

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Azcares de frutas de bajo ayudan a mantener ndice glicmico constantes los niveles de glucosa en sangre. Clarification provided it helps to maintain steady blood glucose levels. Art.13(1) blueberry extracts blueberry can support maintainig of proper night vision

Art.13(1) carotnodes

Art.13(1) Coffee

Art.13(1) PROPOLIS

Non-compliance with the Regulation not validated 2011;9(4):2082 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation not validated 2011;9(6):2244 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. carotnodes comme le Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 bta-carotne, le because on the basis of the scientific proteins and lipids from lycopne et la lutne evidence assessed, this claimed effect oxidative damage sont des anti-oxydants for this food has not been protecteurs des lipides substantiated. des couches profondes coffee contributes to Non-compliance with the Regulation maintenance of normal 2011;9(4):2057 healthy lood glucose because on the basis of the scientific blood glucose levels. evidence assessed, this claimed effect concentrations for this food has not been substantiated. contributes to ease Non-compliance with the Regulation not validated 2010;8(10):1810 throat discomfort because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

727

Non-authorised

2638

Non-authorised

1948

Non-authorised

1100

Non-authorised

3184

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Chicory oligofructose

Art.13(1) Dietary fibre

Art.13(1) Dietary fibre

contributes to your Non-compliance with the Regulation Increasing numbers of 2011;9(6):2228 body's natural defences;because on the basis of the scientific gastro-intestinal evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation. dietary fibre as part of Non-compliance with the Regulation not validated 2010;8(10):1735 diet low in sugars; because on the basis of the scientific -dietary fibre induces a evidence assessed, this food is not low glycemic response; sufficiently characterised for a -dietary fibre helps to scientific assessment of this claimed control/ balance blood effect and the claim could not therefore insulin/glucose level. be substantiated. -helps to control/ balance blood insulin/ glucose level -can help to reduce the glycemic index of a meal -has beneficial effects on blood glucose and blood insulin level -is suitable for diabetics dietary fibre: - has Non-compliance with the Regulation maintenance of normal 2009;7(9):1255 beneficial effects on the because on the basis of the scientific blood cholesterol cholesterol level (in the evidence assessed, this food is not concentrations blood) - helps to sufficiently characterised for a maintain healthy scientific assessment of this claimed cholesterol levels effect and the claim could not therefore be substantiated.

Non-authorised

773

Non-authorised

4308

Non-authorised

750

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Diet rich in whole grain

diets rich in whole grain Non-compliance with the Regulation not validated foods promote heart because on the basis of the scientific health evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Lactarius deliciosus et draine les reins Non-compliance with the Regulation Increase in renal water Lactarius piperatus because on the basis of the scientific elimination evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Carbohydrates with a due to its (modified) Non-compliance with the Regulation not validated reduced glycemic responsecarbohydrate because on the basis of the scientific composition, this food evidence assessed, this food is not has a lower blood sufficiently characterised for a glucose and insulin scientific assessment of this claimed response; -this food has effect and the claim could not therefore a [x%] lower impact on be substantiated. blood sugar levels than comparable foods and thus helps to maintain more steady blood sugar levels Art.13(1) Taurine effet relaxant sur le Non-compliance with the Regulation maintenance of normal coeur et les muscles because on the basis of the scientific muscle function evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2010;8(10):1766

Non-authorised

1431

2010;8(10):1742

Non-authorised

3410

2010;8(2):1491

Non-authorised

484

2011;9(4):2035

Non-authorised

1949

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructose, Glucose, Maltodextrine, Milk protein concentrate, 5.Soy protein concentrate, Creatine, Vitamin C, Magnezium Oxide, Zinc Oxide,Alimentary flavors

Art.13(1) Fats

energizer and proteic food supplement / recomended for fast increase of energy, strenght and muscular development / recovery musular energy after physical and mental effort fats are essential to the body.

Non-compliance with the Regulation growth or maintenance 2011;9(6):2247 because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

4712

Non-compliance with the Regulation function of the cell because on the basis of the scientific membrane evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated.

2011;9(6):2220

Non-authorised

2900

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructo-oligosaccharides from sucrose

fructooligosaccharides/o Non-compliance with the Regulation maintenance of normal 2011;9(4):2023 ligofructose support the because on the basis of the scientific (fasting) blood regulation of blood lipid evidence assessed, this claimed effect concentrations of levels for this food has not been triglycerides fructooligosaccharides/o substantiated. ligofructose support the regulation of lipid metabolism - combined to a balanced diet contribute to healthy blood cholesterol level; - contribute to / support the regulation of the blood lipid level; - contribute to / support the regulation of the cholesterol level

Non-authorised

805

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructo-oligosaccharides from sucrose

Art.13(1) Glutaminian

Art.13(1) Acacia gum (gum arabic)

fructooligosaccharides/o Non-compliance with the Regulation maintenance of normal 2011;9(4):2023 ligofructose support the because on the basis of the scientific blood LDL-cholesterol regulation of blood lipid evidence assessed, this claimed effect concentrations levels for this food has not been fructooligosaccharides/o substantiated. ligofructose support the regulation of lipid metabolism - combined to a balanced diet contribute to healthy blood cholesterol level; - contribute to / support the regulation of the blood lipid level; - contribute to / support the regulation of the cholesterol level glutamine improves Non-compliance with the Regulation growth or maintenance 2011;9(6):2225 body metabolism because on the basis of the scientific of muscle mass evidence assessed, this claimed effect for this food has not been substantiated. gum acacia helps to Non-compliance with the Regulation maintenance of normal 2011;9(4):2022 reduce blood because on the basis of the scientific blood LDL-cholesterol cholesterol ; gum acacia evidence assessed, this claimed effect concentrations contribute to maintain a for this food has not been good cardiovascular substantiated. health ; gum acacia helps to control blood cholesterol level

Non-authorised

805

Non-authorised

3185

Non-authorised

841

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Acacia gum (gum arabic)

Art.13(1) Carbohydrate electrolyte drinks

Art.13(1) Punica granatum-fruitsPunicaceae-DadhimaPomegranate

gum acacia support Non-compliance with the Regulation Maintenance of faecal 2011;9(4):2022 renal function ; gum because on the basis of the scientific nitrogen content and acacia helps renal evidence assessed, this claimed effect blood urea levels function during high for this food is not a beneficial protein diet ; gum physiological effect as required by the acacia helps to maintain Regulation. kidney metabolism help delay the onset of Non-compliance with the Regulation reduction in the rated 2011;9(6):2211 fatigue during a because on the basis of the scientific perceived subsequent bout of evidence assessed, this claimed effect exertion/effort during exercise helps you to for this food has not been exercise perform for longer substantiated. improves subsequent endurance capacity can help the body recover more effectively from exercise ensures adequate hydration and restores endurance capacity liquid carbohydrate is as effective, if not more effective than a solid form for glycogen resynthesis help to maintain a Non-compliance with the Regulation maintenance of normal 2010;8(10):1750 normal glucose level. because on the basis of the scientific blood glucose evidence assessed, this claimed effect concentrations for this food has not been substantiated.

Non-authorised

840, 1975

Non-authorised

467

Non-authorised

4471

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Unsaturated fats/fatty acidshelp to maintain the Non-compliance with the Regulation function of the cell function and fluidity of because on the basis of the scientific membrane the cellular membranes evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) rich in trytophane help to reduce Non-compliance with the Regulation Contribution to the carbohydrate addiction. because on the basis of the scientific maintenance or help to prevent evidence assessed, this claimed effect achievement of a carbohydrate for this food has not been normal body weight consumption substantiated. Art.13(1) Lactobacillus casei CNCM Ihelps balance the Non-compliance with the Regulation Lactobacillus casei DG -1572 DG intestinal flora because on the basis of the scientific CNCM I-1572 and evidence assessed, this claimed effect decreasing potentially for this food has not been pathogenic gastrosubstantiated. intestinal microorganisms Art.13(1) choline-stabilized helps improve hair Non-compliance with the Regulation contribution to normal orthosilicic acid (ch-OSA) thickness because on the basis of the scientific formation of collagen (The mineral silicon is - helps maintain hair evidence assessed, this claimed effect and connective tissue present in water as strength and hair for this food has not been orthosilicic acid; ch-OSA is elasticity substantiated. a stabilized and - helps improve hair concentrated source of volume orthosilicic acid) - helps maintain healthy hair

2011;9(6):2220

Non-authorised

2911

2011;9(4):2073

Non-authorised

604

2009;7(9):1247, 2012;10(6):2723

Non-authorised 2949 (expiry of transitional period 02/01/2014)

2011;9(6):2259

Non-authorised

1719

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) choline-stabilized orthosilicic acid (ch-OSA) (The mineral silicon is present in water as orthosilicic acid; ch-OSA is a stabilized and concentrated source of orthosilicic acid)

helps improve hair Non-compliance with the Regulation contribution to normal thickness because on the basis of the scientific formation of hair and - helps maintain hair evidence assessed, this claimed effect nails strength and hair for this food has not been elasticity substantiated. - helps improve hair volume - helps maintain healthy hair Art.13(1) Black rice (Oriza sativa helps keep the heart Non-compliance with the Regulation protection of DNA, indica), consumed as such, and arteries healthy #C because on the basis of the scientific proteins and lipids from or the bran (pigment helps maintain healthy evidence assessed, this claimed effect oxidative damage fraction) of black rice used blood cholesterol #B for this food has not been as a food ingredient in helps protect the body substantiated. foods, in particular tissue and cells from yoghurts, baked products, oxidative damage #A food supplements and certain foods for a particular nutritional use. Art.13(1) Evening primrose oil and helps maintain bone Non-compliance with the Regulation maintenance of normal fish oil density and strength by because on the basis of the scientific bone increasing intestinal evidence assessed, this claimed effect calcium absorption for this food has not been substantiated. Art.13(1) Para-aminobenzoic Acid helps maintain hair, Non-compliance with the Regulation Maintenance of normal nails and skin in because on the basis of the scientific structure and optimum condition evidence assessed, this claimed effect appearance of hair and has not been linked to a function of the nails body, as required by Article 13 of the Regulation.

2011;9(6):2259

Non-authorised

1719

2011;9(6):2246

Non-authorised

1174

2011;9(6):2224

Non-authorised

1552

2011;9(6):2228

Non-authorised 1746 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Para-aminobenzoic Acid

helps maintain hair, nails and skin in optimum condition

Art.13(1) cholinestabilized orthosilicichelps reduce the acid (ch-OSA) appearance (The mineral silicon (Si) is of wrinkles present in water as - helps improve skin orthosilicic acid (OSA), ch- elasticity OSA is a stabilized and concentrated source of orthosilicic acid) Art.13(1) Coffea arabica helps refresh body and mind /helps to revive you /helps keeping you alert

Non-compliance with the Regulation Maintenance of 2011;9(6):2228 because on the basis of the scientific structure and elasticity evidence assessed, this claimed effect of the skin has not been linked to a function of the body, as required by Article 13 of the Regulation. Non-compliance with the Regulation contribution to normal 2011;9(6):2259 because on the basis of the scientific formation of collagen evidence assessed, this claimed effect and connective tissue for this food has not been substantiated.

Non-authorised 1746 (expiry of transitional period 02/01/2014)

Non-authorised

333

Non-compliance with the Regulation Kidneys health, 2010;8(10):1742 because on the basis of the scientific urinary health, evidence assessed, this claimed effect bladder health, health for this food is not sufficiently defined of lower urinary tract, to be able to be assessed and the blood health, claim could not therefore be elimination, "urinary substantiated. system benefits" and/or supports/promotes the excretory function of the kidney Art.13(1) cholinestabilized orthosilicichelps support bone Non-compliance with the Regulation maintenance of normal 2011;9(6):2259 acid (ch-OSA) quality by because on the basis of the scientific bone (The mineral silicon (Si) is stimulating bone evidence assessed, this claimed effect present in water as collagen for this food has not been orthosilicic acid (OSA), ch- - helps maintain strong substantiated. OSA is a stabilized and bones concentrated source of orthosilicic acid)

Non-authorised

1188

Non-authorised

335

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) cholinestabilized orthosilicichelps support bone acid (ch-OSA) quality by (The mineral silicon (Si) is stimulating bone present in water as collagen orthosilicic acid (OSA), ch- - helps maintain strong OSA is a stabilized and bones concentrated source of orthosilicic acid)

Non-compliance with the Regulation contribution to normal because on the basis of the scientific formation of collagen evidence assessed, this claimed effect and connective tissue for this food has not been substantiated.

2011;9(6):2259

Non-authorised

335

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactulose

helps the development Non-compliance with the Regulation Decreasing potentially 2010;8(10):1806 of the intestinal flora because on the basis of the scientific pathogenic gastro[APPENDIX 1]; evidence assessed, this claimed effect intestinal stimulates the growth of for this food has not been microorganisms Bifidobacteria in the substantiated. colon; is a prebiotic; is bifidogenic; promotes healthy/balanced/good gut bacteria; supports healthy gastrointestinal flora; promotes healthy gut bacteria or microflora; promotes good digestive health; promotes gastrointestinal/bowel/g ut/colonic health; promotes proper/healthy bowel function; supports healthy gastrointestinal flora; improves intestinal conditions; promotes intestinal health; promotes healthy conditions in the colon; improves digestive/bowel function; improves digestive/gut comfor

Non-authorised

806

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Conjugated Linoleic acid helps to control fat Non-compliance with the Regulation contribution to the (cis-9, trans-11 and trans- metabolism because on the basis of the scientific maintenance or 10, cis-12) influences lipid evidence assessed, this claimed effect achievement of a metabolism and for this food has not been normal body weight storage. substantiated. increases lean muscle mass reduces body fat percentage helps to reduce body fat mass while increasing lean body mass helps to reduce body fat mass helps to reduce the amount of fat you store after eating helps to decrease the amount of fat stored in your body helps to reduce you abdominal fat mass helps to reduce fat mass in your abdomen and thighs helps to improve your body shape helps to increase lean body mass helps reduce weight gain helps to reduce SAD

2010;8(10):1794

Non-authorised

2892

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hyaluronic Acid

Non-compliance with the Regulation Maintenance of because on the basis of the scientific structure and elasticity evidence assessed, this claimed effect of the skin has not been linked to a function of the body, as required by Article 13 of the Regulation. Art.13(1) Evening primrose oil helps to keep normal Non-compliance with the Regulation maintenance of normal (Oenothera biennis) blood cholesterol because on the basis of the scientific blood LDL-cholesterol contains gamalinolenic acid evidence assessed, this claimed effect concentrations for this food has not been substantiated. Art.13(1) Evening primrose oil helps to keep normal Non-compliance with the Regulation Maintenance of normal (Oenothera biennis) blood preassure because on the basis of the scientific blood pressure contains gamalinolenic acid evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Mix of Glucose-Fructose helps to lower level of Non-compliance with the Regulation Decreasing the the consumed alcohol in because on the basis of the scientific absorption of alcohol the body by evidence assessed, this claimed effect decelerating of the for this food is not a beneficial absorbin of alcohol physiological effect as required by the Regulation.

(sagittal abdominal diameter) helps to prevent the yoyo-effect after a diet helps to reduce muscle protein loss during a diet helps to increase feelings of fullness and satiety helps to keep good health of skin helps to keep young look of skin

2011;9(6):2228

Non-authorised 3131 (expiry of transitional period 02/01/2014)

2011;9(4):2059

Non-authorised

2661

2011;9(4):2059

Non-authorised

2662

2011;9(6):2228

Non-authorised

648

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) L-Theanine

helps to maintain an Non-compliance with the Regulation maintenance of normal optimal relaxation; helps because on the basis of the scientific sleep to support the relaxation evidence assessed, this claimed effect ; helps to maintain a for this food has not been healthy sleep substantiated. Art.13(1) isoflavones helps to maintain Non-compliance with the Regulation Maintenance of joints mobility of joint during because on the basis of the scientific and after climacterium evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) zeaxantin helps to maintain Non-compliance with the Regulation maintenance of normal normal vision, because on the basis of the scientific vision recomended in dry and evidence assessed, this claimed effect irritable eyes, for this food has not been incineration and substantiated. ephiphora and inflamed eyelids, helps to preserve elasticity and permeability of capilars of retina and supports good blood circulation in eyes Art.13(1) Evening primrose oil helps to maintain proper Non-compliance with the Regulation Maintenance of normal (Oenothera biennis) appearence of skin, because on the basis of the scientific structure and contains gamalinolenic acidhelps to maintain evidence assessed, this claimed effect appearance of the skin elasticity, tenderness has not been linked to a function of the and health of skin body, as required by Article 13 of the Regulation.

2011;9(6):2238

Non-authorised

1737

2010;8(2):1493

Non-authorised

3144

2010;8(10):1724

Non-authorised

2888

2011;9(4):2059

Non-authorised 2660 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bromelain

Non-compliance with the Regulation Vascular and vein 2011;9(6):2228 because on the basis of the scientific health evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) isoflavones helps to reduce Non-compliance with the Regulation Reduction of vasomotor 2011;9(7):2264, untoward effects of because on the basis of the scientific symptoms associated 2012;10(8):2847 climacterium e.g. hot evidence assessed, the evidence with menopause flush, exudation, strong provided is insufficient to substantiate heartbeat this claimed effect for this food. Art.13(1) CoffeeSLENDER Tablets i). As an aid to weight Non-compliance with the Regulation Contribution to the 2011;9(4):2057 made from an extract from loss and weight control because on the basis of the scientific maintenance or green coffee beans as part of a calorie evidence assessed, this claimed effect achievement of a (Svetol) the active controlled diet. for this food has not been normal body weight principle of which is:-=5- ii). Acts by reducing substantiated. caffeoylquinic acid or absorption of sugar (Chlorogenic acid) =45%, (glucose) from the Caffeine = 2%, 3digestive tract. caffeoylquinic acid =10% Art.13(1) Oligofructose-enriched increases/ promotes/ Non-compliance with the Regulation not validated 2011;9(6):2244 inulin (specific selection of enhances Calcium because on the basis of the scientific short & long chains) from absorption. evidence assessed, this food is not chicory sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

helps to maintein natural blood fluidity and vessel patence

Non-authorised

1480

Non-authorised 3154 (expiry of transitional period 02/01/2014) Non-authorised 2031

Non-authorised

771

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Fructose, L/Carnitine

Art.13(1) Inulin/oligofructose from chicory

instant drink which helps burning fats / accelerate the fats metabolism / increase physical performances and effort resistance inulin/ oligofructose enhances calcium absorption

Non-compliance with the Regulation contribution to the because on the basis of the scientific maintenance or evidence assessed, this claimed effect achievement of a for this food has not been normal body weight substantiated.

2011;9(6):2246

Non-authorised

4709

Art.13(1) Inulin/ oligofructose from chicory

Art.13(1) Iodine

Non-compliance with the Regulation not validated 2011;9(6):2244 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. inulin/ oligofructose Non-compliance with the Regulation not validated 2011;9(6):2244 from chicory : because on the basis of the scientific - helps to regulate evidence assessed, this food is not cholesterol level; sufficiently characterised for a - contributes to healthy scientific assessment of this claimed blood cholesterol level; effect and the claim could not therefore - helps to manage be substantiated. cholesterol level; - helps to maintain healthy blood cholesterol level. is important for visual Non-compliance with the Regulation maintenance of vision 2009;7(9):1214 function and eye because on the basis of the scientific moisture. evidence assessed, this claimed effect for this food has not been substantiated.

Non-authorised

770

Non-authorised

804

Non-authorised

356

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) SAMe (Sadenosylmethionine)

joint health, mobility and Non-compliance with the Regulation Maintenance of joints joint comfort additional because on the basis of the scientific statement : If you are evidence assessed, this claimed effect taking prescription for this food has not been antidepressant substantiated. medications, consult your physician before using this product. Individual with bipolar (manic) depression should not use this product unless under medical supervision. Art.13(1) Carbohydrates with a low low GI [carbohydrate] Non-compliance with the Regulation not validated glycaemic index (GI) foods help you feel because on the basis of the scientific fuller for longer evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) Carbohydrates with a low low glycemic Non-compliance with the Regulation not validated glycaemic response carbohydrates / low because on the basis of the scientific glycemic [carbohydrate] evidence assessed, this food is not diet helps maintain and sufficiently characterised for a improve blood glucose scientific assessment of this claimed control; effect and the claim could not therefore -low glycemic be substantiated. carbohydrates / low glycemic [carbohydrate] diet helps in the management of regular blood glucose levels;

2010;8(2):1493

Non-authorised

1973

2010;8(2):1491

Non-authorised

482

2010;8(2):1491

Non-authorised

483

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lycopene (from Tomato extract)

Art.13(1) Iodine

Art.13(1) Iodine

Art.13(1) Fermented milk with Lactobacillus paracasei lpc 37

lycopene is an Non-compliance with the Regulation protection of DNA, antioxidant and helps to because on the basis of the scientific proteins and lipids from protect the bodys evidence assessed, this claimed effect oxidative damage cells/helps to maintain for this food has not been intact body cells. substantiated. Lycopene or a diet rich in lycopene helps to maintain intact cell DNA/contributes to healthy ageing by maintaining intact cell DNA/ may contribute to Non-compliance with the Regulation maintenance of hair preserve healthy hair, because on the basis of the scientific nails and skin. evidence assessed, this claimed effect for this food has not been substantiated. may contribute to Non-compliance with the Regulation maintenance of nails preserve healthy hair, because on the basis of the scientific nails and skin. evidence assessed, this claimed effect for this food has not been substantiated. microflora of the Non-compliance with the Regulation not validated gastrointestinal tract because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2011;9(4):2031

Non-authorised

2082

2009;7(9):1214

Non-authorised

370

2009;7(9):1214

Non-authorised

370

2010;8(2):1470

Non-authorised

3032

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) All minerals

mineral(s) help the Non-compliance with the Regulation multivitamin development of all body because on the basis of the scientific supplementation to structures. -mineral(s) evidence assessed, this claimed effect sustain vitality while are essential for your for this food is not sufficiently defined aging and body. -we need to be able to be assessed and the development mineral(s) to make the claim could not therefore be body functions work. - substantiated. mineral(s) is a factor in the maintenance of good health Art.13(1) Cranberry extract powder natural antioxidant, Non-compliance with the Regulation protection of DNA, (Vaccinium macrocarpon) protect organism from because on the basis of the scientific proteins and lipids from oxidative demage, evidence assessed, this claimed effect oxidative damage natural way to avoid for this food has not been risks caused by substantiated. oxidation and peroxidation process Art.13(1) Lutein natural antioxidant, Non-compliance with the Regulation protection of DNA, protect organism from because on the basis of the scientific proteins and lipids from oxidative damage, evidence assessed, the evidence oxidative damage natural way to avoid provided is insufficient to substantiate risks caused by this claimed effect for this food. oxidation and peroxidation process Art.13(1) blueberry extracts natural antioxidant, Non-compliance with the Regulation protection of DNA, protect organism from because on the basis of the scientific proteins and lipids from oxidative damage, evidence assessed, this claimed effect oxidative damage natural way to avoid for this food has not been risks caused by substantiated. oxidation and peroxidation process

2011;9(4):2077

Non-authorised

217

2010;8(10):1752

Non-authorised

2637

2011;9(4):2030

Non-authorised

3427

2010;8(10):1752

Non-authorised

2639

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) extract of guarana (Paullinia cupana)

Art.13(1) Fermented milk with Lactobacillus paracasei lpc 37

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Art.13(1) slnium participe la protection Non-compliance with the Regulation protection against contre les mtaux because on the basis of the scientific heavy metals lourds evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Gamma-linolenic acid + partners in maintaining Non-compliance with the Regulation Reduction of eicosapentaenoic acid a healthy immune because on the basis of the scientific inflammation (GLA+EPA) system evidence assessed, this claimed effect for this food is not a beneficial physiological effect as required by the Regulation. Art.13(1) Acidic water - based, non poses minimal risk of Non-compliance with the Regulation not validated alcoholic flavoured tooth erosion because on the basis of the scientific beverages in relation to tooth evidence assessed, this food is not erosion, helps keep sufficiently characterised for a teeth healthy scientific assessment of this claimed minimises loss of dental effect and the claim could not therefore enamel be substantiated.

natural antioxidant, protect organism from oxidative damage, powerful antioxidants beneficial to human health natural defence /immune system

Non-compliance with the Regulation protection of DNA, 2010;8(10):1752 because on the basis of the scientific proteins and lipids from evidence assessed, this claimed effect oxidative damage for this food has not been substantiated. 2010;8(2):1470

Non-authorised

2663

Non-authorised

3031

2010;8(10):1727

Non-authorised

383

2011;9(4):2061

Non-authorised

641

2011;9(4):2083

Non-authorised

1170

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) omega 3

pourraient amliorer Non-compliance with the Regulation Increase in calcium labsorption intestinale because on the basis of the scientific absorption leading to du calcium evidence assessed, this claimed effect an increase in calcium for this food has not been retention substantiated. Art.13(1) omega 3 pourrait amliorer la Non-compliance with the Regulation maintenance of normal fixation du calcium sur because on the basis of the scientific bone l'os evidence assessed, this claimed effect for this food has not been substantiated. Art.13(1) Lactobacillus reuteri ATCC probiotic beneficially Non-compliance with the Regulation decreasing potentially 55730 affects the intestinal because on the basis of the scientific pathogenic intestinal flora supports a healthy evidence assessed, this claimed effect microorganisms intestinal flora balances for this food has not been the intestinal flora substantiated. Art.13(1) Bifidobacterium animalis probiotic enhances Non-compliance with the Regulation decreasing potentially Lafti B94 (CBS118.529) levels of beneficial because on the basis of the scientific pathogenic intestinal microflora balances evidence assessed, this claimed effect microorganisms your intestinal for this food has not been microflora beneficially substantiated. affects the intestinal flora supports a balanced beneficial gastro-intestinal microflora

2011;9(6):2242

Non-authorised

606

2011;9(6):2242

Non-authorised

607

2009;7(9):1243

Non-authorised

904

2009;7(9):1232

Non-authorised

867

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Name of Food product: fermented dairy products

probiotic enhances Non-compliance with the Regulation decreasing potentially 2009;7(9):1233 levels of beneficial because on the basis of the scientific pathogenic intestinal microflora balances evidence assessed, this claimed effect microorganisms Description of food in termsyour intestinal for this food has not been of food legislation microflora beneficially substantiated. categories: food not affects the intestinal covered by specific food flora supports a legislation balanced beneficial gastro-intestinal Was food on Irish market microflora before 1st July 2007: Yes Art.13(1) Lactobacillus rhamnosus probiotic helps to Non-compliance with the Regulation decreasing potentially 2009;7(9):1244 HN001 AGAL NM97/09514 improve the level of because on the basis of the scientific pathogenic intestinal natural good bacteria in evidence assessed, this claimed effect microorganisms your body maintains the for this food has not been balance of healthy substantiated. microflora beneficially affects the intestinal flora Art.13(1) Vitamine E and Slnium protect fatty acids of Non-compliance with the Regulation protection of lipids in 2011;9(6):2246 skin cell membranes because on the basis of the scientific the skin from UVfrom oxidation after sun evidence assessed, this claimed effect induced photo-oxidative exposure for this food has not been damage substantiated. Art.13(1) Calcium phosphoryl remineralizes/restores Non-compliance with the Regulation maintenance of tooth 2011;9(6):2267 oligosaccharide tooth enamel after because on the basis of the scientific mineralisation meals evidence assessed, this claimed effect increases tooth surface for this food has not been hardness substantiated. helps strengthen teeth.

Non-authorised

1376

Non-authorised

908

Non-authorised

4290

Non-authorised

337

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Pleurotus Eryngii

rgule la physiologie du pancras et le mtabolisme des graisses

Art.13(1) Vitamins, minerals, lysine scientifically proven to and/or arginine and/or support attention and taurine mental performance (Pharmaton Kiddi)

Art.13(1) Bifidobacterium animalis support the natural ssp. lactis Bf-6/Bif-6/CB111beneficial gut flora ; and Lactobacillus johnsonii contribute to healthy La-1/ACD-1/CLbA22 (A/B- intestinal microflora ; 61) contribute to healthy digestive system Art.13(1) MSM methylsulfonylmetan supports control of organism pH balance

Art.13(1) Lactobacillus johnsonii La- supports the natural 19/CLbA5 beneficial gut flora ; contributes to healthy intestinal microflora

Non-compliance with the Regulation Improvement of the 2011;9(6):2228 because on the basis of the scientific digestion of evidence assessed, this claimed effect macronutrients (e.g. for this food is not a beneficial carbohydrates, proteins physiological effect as required by the and lipids) Regulation. Non-compliance with the Regulation not validated 2011;9(4):2083 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Non-compliance with the Regulation 'Intestinal flora/digestive2010;8(2):1470, because on the basis of the scientific health' 2012;10(8):2858 evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Non-compliance with the Regulation maintenance of normal 2010;8(10):1746 because on the basis of the scientific acid-base balance evidence assessed, this claimed effect for this food has not been substantiated. Non-compliance with the Regulation not validated 2010;8(2):1470 because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

3519

Non-authorised

1677

Non-authorised 4231 (expiry of transitional period 02/01/2014)

Non-authorised

387

Non-authorised

4230

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bifidobacterium animalis supports the natural ssp. lactis Bf-6/Bif-6/CB111beneficial gut flora ; contributes to healthy intestinal microflora ; contributes to healthy digestive system Art.13(1) Bifidobacterium animalis supports the natural ssp. lactis Bf-6/Bif-6/CB111beneficial gut flora ; contributes to healthy intestinal microflora ; contributes to healthy digestive system Art.13(1) Bifidobacterium animalis supports the natural ssp. lactis Bf-6/Bif-6/CB111beneficial gut flora ; contributes to healthy intestinal microflora ; contributes to healthy digestive system

Non-compliance with the Regulation decreasing potentially 2010;8(10):1767 because on the basis of the scientific pathogenic gastroevidence assessed, this claimed effect intestinal for this food has not been microorganisms substantiated.

Non-authorised

4228

Non-compliance with the Regulation increasing numbers of 2010;8(10):1767 because on the basis of the scientific gastro-intestinal evidence assessed, this claimed effect microorganisms for this food is not a beneficial physiological effect as required by the Regulation. Non-compliance with the Regulation healthy and balanced 2010;8(10):1767 because on the basis of the scientific digestive system evidence assessed, this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated. Art.13(1) Lactobacillus johnsonii La- supports the natural Non-compliance with the Regulation not validated 2010;8(2):1470 1/ACD-1/CLbA22 beneficial gut flora ; because on the basis of the scientific contributes to healthy evidence assessed, this food is not intestinal microflora ; sufficiently characterised for a contributes to healthy scientific assessment of this claimed digestive system effect and the claim could not therefore be substantiated. Art.13(1) Vitamin K2 vitamin K2 contributes Non-compliance with the Regulation Contribution to the 2009;7(9):1228, to vascular health. because on the basis of the scientific normal function of the 2012;10(6):2714 evidence assessed, this claimed effect heart and blood vessels for this food has not been substantiated.

Non-authorised

4228

Non-authorised

4228

Non-authorised

4229

Non-authorised 125 (expiry of transitional period 02/01/2014)

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Water

water is an essential Non-compliance with the Regulation basic requirement of nutrient for life; because on the basis of the scientific all living things -water helps all body evidence assessed, this claimed effect functions to work for this food is not sufficiently defined properly; to be able to be assessed and the -water facilitates other claim could not therefore be nutrients to work substantiated. properly; -water carries nutrients throughout the whole body; -water helps remove waste products from the body; -water is actively involved in body functioning; -recommended water intake is typically 1 to 1.5 litres/ day (sedentary/ temperate conditions) in addition to water contained in food.

2011;9(4):2075

Non-authorised

1207

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Very low calorie diet (VLCD) Programme

Art.13(1) Dietary fibre

when you are on Food Non-compliance with the Regulation reduction in body fat 2011;9(6):2271 packs - your body uses because on the basis of the scientific mass while maintaining its stored fat to make up evidence assessed, this claimed effect lean body mass the difference (of for this food has not been energy). substantiated. evidence suggests that VLCDs do not accelerate the loss of lean tissue weight loss is 3 parts fat and 1 part lean during weight loss. the body breaks down fat to make up the deficit. When you lose weight it comes off in the ratio 3 parts fat to 1 part lean tissue and that's true of any diet. dietary fibre helps to Non-compliance with the Regulation not validated 2010;8(10):1735 balance blood glucose because on the basis of the scientific level; evidence assessed, this food is not dietary fibre helps to sufficiently characterised for a regulate glucose level; scientific assessment of this claimed dietary fibre effect and the claim could not therefore contributes to healthy be substantiated. glucose level; dietary fibre helps to maintain healthy glucose level.

Non-authorised

1412

Non-authorised

746

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Dietary fibre

dietary fibre helps to Non-compliance with the Regulation not validated 2010;8(10):1735 maintain normal because on the basis of the scientific bowel/colonic function; evidence assessed, this food is not dietary fibre promotes sufficiently characterised for a bowel regularity; scientific assessment of this claimed ensures a healthy effect and the claim could not therefore digestive be substantiated. system/function. Art.13(1) Morinaga Bifidobacterium Bifidobacterium longum Non-compliance with the Regulation decreasing potentially 2011;9(4):2041 longum BB536 BB536 is a probiotic because on the basis of the scientific pathogenic intestinal that promotes a healthy evidence assessed, this claimed effect microorganisms balance of intestinal for this food has not been bacteria substantiated. Bifidobacterium longum BB536 is a probiotic that suppresses the growth of harmful intestinal bacteria Art.13(1) Bioflavonoids Bioflavonoids support a Non-compliance with the Regulation not validated 2011;9(4):2082 healthy immune because on the basis of the scientific system. evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

Non-authorised

744

Non-authorised

3005

Non-authorised

1920

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Hydroxypropyl methylcellulose (HPMC) Dietary fibre

HPMC promotes good Non-compliance with the Regulation maintenance of normal 2010;8(10):1739 digestive health and because on the basis of the scientific bowel function regularity. HPMC evidence assessed, this claimed effect promotes good for this food has not been digestive health. substantiated. HPMC promotes regularity. HPMC helps maintain good digestive health and regularity. HPMC helps maintain good digestive health. HPMC helps maintain regularity. HPMC helps promote better digestion. Soluble fibre such as HPMC helps promote better digestion. HPMC helps promote better digestion. HPMC helps promote a healthy digestive system. Soluble fibre such as HPMC promotes a healthy digestive system. HPMC promotes a healthy digestive system. HPMC/ dietary fibre helps to maintain normal bowel/colonic function.

Non-authorised

812

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Menaquinone-7 (MK-7, a form of vitamin K2)

Art.13(1) Chlorophyllin [Sodium copper chlorophyllin]

HPMC/dietary fibre promotes regularity. HPMC/dietary fibre ensures a healthy digestive system/function. MK-7 is a highly Non-compliance with the Regulation function of the heart bioavailable form of because on the basis of the scientific and blood vessels vitamin K that helps evidence assessed, the evidence maintain a healthy provided is insufficient to substantiate cardiovascular system this claimed effect for this food. MK-7 is a highly bioavailable form of vitamin K that helps keep the heart and blood vessels healthy Provides antioxidant Non-compliance with the Regulation reduction of gastroprotection. because on the basis of the scientific intestinal discomfort For daily detoxification evidence assessed, this claimed effect support. for this food has not been Research indicates that substantiated. chlorophyllin may modulate the activity of detoxification enzymes and provide antioxidant protection against free radicals.

2009;7(9):1228

Non-authorised

2880

2011;9(6):2248

Non-authorised

1717

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bacillus subtilis Natto

Helps support a healthy heart Helps maintain a healthy heart

Art.13(1) Bacillus subtilis HU58

Art.13(1) Bacillus subtilis HU58

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. Contains Probiotic Non-compliance with the Regulation not validated Contains healthy because on the basis of the scientific bacteria evidence assessed, this food is not Maintains dominance sufficiently characterised for a of good bacteria in the scientific assessment of this claimed gut effect and the claim could not therefore be substantiated. Contributes to/ Non-compliance with the Regulation not validated supports / maintains because on the basis of the scientific natural evidence assessed, this food is not resistance/defence sufficiently characterised for a Strengthens your scientific assessment of this claimed bodys natural defence effect and the claim could not therefore Stimulates the immune be substantiated. system Stimulates the specific and non specific immune system Supports your natural defences Helps to regulate the b

2010;8(2):1470

Non-authorised

3024

2009;7(9):1247

Non-authorised

917

2009;7(9):1247

Non-authorised

1092

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bacillus subtilis Natto

Contributes to/ supports / maintains natural resistance/defence Strengthens your bodys natural defence Stimulates the immune system Stimulates the specific and non specific immune system Supports your natural defences Helps to regulate the b For good intestinal health Helps keep your digestive system in balance Helps gastrointestinal tract comfort Maintains a healthy intestinal environment and functionality Maintain the balance of microflora Promotes and maintains intestinal hea

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2010;8(2):1470

Non-authorised

3022

Art.13(1) Bacillus subtilis HU58

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1091

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Bacillus subtilis Natto

For good intestinal Non-compliance with the Regulation not validated health because on the basis of the scientific Helps keep your evidence assessed, this food is not digestive system in sufficiently characterised for a balance scientific assessment of this claimed Helps gastrointestinal effect and the claim could not therefore tract comfort be substantiated. Maintains a healthy intestinal environment and functionality Maintain the balance of microflora

2010;8(2):1470

Non-authorised

3023

Promotes and maintains intestinal hea Art.13(1) Lactic acid bacteria/ Entero Helps balancing coccus faecium intestinal activity. Helps decreasing the number of loose stools Helps decreasing the number of loose stools in connection with use of antibiotics

Non-compliance with the Regulation not validated because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated.

2009;7(9):1247

Non-authorised

1595

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(1) Lactobacillus delbruekii(lactis)

Helps maintain a Non-compliance with the Regulation not validated healthy balance of because on the basis of the scientific beneficial bacteria evidence assessed, this food is not promotes the positive sufficiently characterised for a balance of the intestinal scientific assessment of this claimed flora effect and the claim could not therefore maintains a healthy gut be substantiated. & gut digestion maintains a healthy intestinal environment Art.13(1) Lactobacillus delbruekii Supports your natural Non-compliance with the Regulation not validated (lactis) defences because on the basis of the scientific Helps to regulate the evidence assessed, this food is not bodys immune sufficiently characterised for a response scientific assessment of this claimed Helps to maintain the effect and the claim could not therefore immune balance be substantiated. Helps maintain a healthy immune system Art.13(1) Fat-reduced cream powder For people with a Non-compliance with the Regulation Reduction of gastric (rich source of milk sensitive stomach; because on the basis of the scientific acid phospholipids) Soothes a sensitive evidence assessed, this claimed effect stomach; for this food is not a beneficial Protects the stomach physiological effect as required by the lining Regulation. Art.13(5) OptiEFAX <em>OptiEFAX&trade;<Non-compliance with the Regulation /em> helps to maintain because on the basis of the scientific healthy blood levels of evidence assessed,<br />this claimed LDL cholesterol&nbsp; effect for this food has not been substantiated

2010;8(2):1470

Non-authorised

3020

2010;8(2):1470

Non-authorised

3021

2011;9(6):2228

Non-authorised

1906

Q-2012-00339

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) OptiEFAX

Art.13(5)

Art.13(5)

Art.13(5)

Art.13(5)

Art.13(5)

<em>OptiEFAX&trade;<Non-compliance with the Regulation /em>&nbsp;helps to because on the basis of the scientific maintain healthy blood evidence assessed,<br />this claimed levels of HDL effect for this food has not been cholesterol substantiated OptiEFAX <p><em>OptiEFAX</e Non-compliance with the Regulation m>&trade; helps to because on the basis of the scientific maintain healthy blood evidence assessed,<br />this claimed levels of effect for this food has not been triglycerides</p> substantiated ApplIn polyphenolic apple <p>Appl'In&reg; Non-compliance with the Regulation extract powder (Malus contributes to decrease because on the basis of the scientific domestica) glycaemic response in evidence assessed,<br />this claimed women</p> effect for this food has not been substantiated Wheat polar lipid extract Contributes to improve Non-compliance with the Regulation skin hydration because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated A combination of flaxseed Contributes to maintain Non-compliance with the Regulation oil and vitamin E skin permeability barrier because on the basis of the scientific function evidence assessed,<br />this claimed effect for this food has not been substantiated Hypo-caloric snacks (KOT Contributes to reduce Non-compliance with the Regulation products) the adipocytes size at because on the basis of the scientific the abdominal level, in evidence assessed,<br />this claimed the context of a loweffect for this food has not been calorie diet substantiated

Q-2012-00340

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014)

Q-2012-00383

Q-2011-00190

Q-2011-01122

Q-2012-00337

Q-2011-00016

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated<br />Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) A combination of thiamin, Helps to increase hair riboflavin, niacin, number pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil (Cucurbita pepo L.)

Q-2012-00334, Q-2012-00335

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014)

Art.13(5) Hyaluronic Acid

Helps to maintain good Non-compliance with the Regulation skin hydration because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Art.13(5) KF2BL20 Helps to maintain hair Non-compliance with the Regulation strength because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Art.13(5) A combination of lycopene, Helps to prepare Non-compliance with the Regulation vitamin E, lutein and sensitive skin from the because on the basis of the scientific selenium inside to improve their evidence assessed,<br />this claimed tolerance to the sun effect for this food has not been substantiated Art.13(5) Rhodiola rosea L. extract Helps to reduce Non-compliance with the Regulation tiredness in case of because on the basis of the scientific stress evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2012-00382

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014)

Q-2012-00381

Q-2012-00592

Q-2012-00336

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Femilub

Art.13(5) Transitech

Art.13(5) Isoleucyl-prolyl-proline (IPP) and valyl-prolylproline (VPP)

Art.13(5) Coffee C21

Helps to reduce vaginal Non-compliance with the Regulation dryness because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Improve transit and Non-compliance with the Regulation durably regulates it because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Peptides IPP and VPP Non-compliance with the Regulation help to maintain normal because on the basis of the scientific blood pressure evidence assessed,<br />this claimed effect for this food has not been substantiated Regular consumption of Non-compliance with the Regulation Coffee C21 contributes because on the basis of the scientific to the maintenance of evidence assessed,<br />this claimed DNA integrity in cells of effect for this food has not been the body substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2012-00571

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014) Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014)

Q-2012-00296

Q-2011-00121

Q-2011-00783

Art.13(5) Bimuno (Bimuno GOS) <p>Regular daily consumption of 1.37 g galactooligosaccharides from Bimuno&reg; may reduce intestinal discomfort</p>

Q-2011-00401

Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014)

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Diacylglycerol (DAG) oil

Substituting your usual vegetable oil with DAG oil helps in the management of body weight through weight loss

Q-2011-00751

Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014)

Art.13(5) Algatrium, containing DHA as raw material for foods/food supplements

Art.13(5) Black tea from Camellia sinensis

Art.13(5) Collagen hydrolysate, a characteristic collagen peptide mixture

Algatrium promotes Non-compliance with the Regulation your antioxidant because on the basis of the scientific response: a singular evidence assessed,<br />this claimed nutritional substance effect for this food has not been that has scientifically substantiated demonstrated in humans a stimulation of the own cells antioxidant defences Black tea helps you to Non-compliance with the Regulation focus attention because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Characteristic collagen Non-compliance with the Regulation peptide mixture because on the basis of the scientific (collagen hydrolysate) evidence assessed,<br />this claimed having a beneficial effect for this food has not been physiological effect on substantiated the maintenance of joint health in physically active people

Q-2008-705

Commission Regulation (EC) No Non-authorised 1168/2009 of 30/11/2009

N/A

Q-2008-434

Commission Regulation (EC) No Non-authorised 1025/2009 of 29/10/2009

N/A

Q-2011-00201

Commission Regulation (EU) No Non-authorised 379/2012 of 03/05/2012

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Elancyl Global Silhouette, Clinically tested as of 14 Non-compliance with the Regulation a combined product days. Your silhouette is because on the basis of the scientific containing either apparently and globally evidence assessed,<br />this food is conjugated linoleic acid or redrawn, resculpted and not sufficiently characterised for a a mix extract of plants and refined at 28 days scientific assessment of this claimed cocoa extract as active effect and the claim could not therefore ingredients be substantiated Art.13(5) Catalgine bouffes de Contributes to the Non-compliance with the Regulation chaleur, containing reduction in the number because on the basis of the scientific concentrated wild fish oil of hot flushes evidence assessed,<br />this claimed from sardines and effect for this food has not been anchovies substantiated Art.13(5) Yestimun, consisting of Daily administration of Non-compliance with the Regulation (1,3)-(1,6)-&beta;-DYestimun strengthens because on the basis of the scientific glucans of brewers yeast the body's defence evidence assessed,<br />this claimed cell wall (100 % during the cold season effect for this food has not been Saccharomyces cerevisiae) substantiated Art.13(5) Live Lactobacillus casei Daily consumption of Non-compliance with the Regulation strain Shirota live Lactobacillus casei because on the basis of the scientific strain Shirota as evidence assessed,<br />this claimed present in a fermented effect for this food has not been milk product helps substantiated maintain the upper respiratory tract defences by helping to support immune functions Art.13(5) Glucosamine Glucosamine Non-compliance with the Regulation contributes to the because on the basis of the scientific maintenance of normal evidence assessed,<br />this claimed joint cartilage effect for this food has not been substantiated

Q-2008-285

Commission Regulation (EC) No Non-authorised 984/2009 of 21/10/2009

N/A

Q-2009-00852

Commission Regulation (EU) No Non-authorised 1161/2010 of 09/12/2010

N/A

Q-2008-667

Commission Regulation (EU) 432/2011 of 04/05/2011

Non-authorised

N/A

Q-2010-00137

Commission Regulation (EU) 1171/2011 of 16/11/2011

Non-authorised

N/A

Q-2011-01113

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014)

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Glucosamine

Art.13(5)

Art.13(5)

Art.13(5)

Art.13(5)

Glucosamine Non-compliance with the Regulation contributes to the because on the basis of the scientific protection of joint evidence assessed,<br />this claimed cartilage exposed to effect for this food has not been excessive motion or substantiated loading and helps to improve the range of motion in joints Gum Periobalance tablets Gum Periobalance , Non-compliance with the Regulation and chewing gum combined with a correct because on the basis of the scientific containing Lactobacilllus oral hygiene, helps re- evidence assessed,<br />this claimed reuteri strains DSM 17938 balancing the oral effect for this food has not been and ATCC PTA 5289 microflora and substantiated improving oral health Bimuno (BGOS) Prebiotic, Helps maintain a Non-compliance with the Regulation a -galacto-oligosaccharidehealthy gastro-intestinal because on the basis of the scientific mixture (GI) function evidence assessed,<br />this claimed effect for this food has not been substantiated Combination of Helps to improve dry Non-compliance with the Regulation blackcurrant seed oil skin condition because on the basis of the scientific (Ribes nigrum), fish oil, evidence assessed,<br />this claimed lycopene from tomato effect for this food has not been (Lycopersicon esculentum) substantiated extract, vitamin C and vitamin E Dairy product (milk Helps to moderate signs Non-compliance with the Regulation beverage) enriched with of anxiety in mildly because on the basis of the scientific milk peptide and stress-sensitive adults evidence assessed,<br />this claimed magnesium due to its milk peptide effect for this food has not been and magnesium substantiated content.

Q-2011-00907

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014)

Q-2009-00373

Commission Regulation (EU) No Non-authorised 382/2010 of 05/05/2010

N/A

Q-2009-00231

Commission Regulation (EU) No Non-authorised 382/2010 of 05/05/2010

N/A

Q-2009-00767

Commission Regulation (EU) 432/2011 of 04/05/2011

Non-authorised

N/A

Q-2008-476

Commission Regulation (EC) No Non-authorised 1025/2009 of 29/10/2009

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated this claimed effect attributes to this food the property of preventing, treating or curing a human disease, or refers to such properties which is prohibited for foods<br />Noncompliance with the Regulation because on the basis of the scientific evidence assessed, Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Prolibra

Helps to reduce body fat while preserving lean&nbsp;muscle

Q-2012-00001

Commission Regulation (EU) No Non-authorised 1066/2013 of 30/10/2013

N/A

Art.13(5) EffEXT

Helps to support joint function by maintaining low levels of plasma Creactive protein

Q-2012-00386

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014)

Art.13(5) LGG MAX multispecies LGG MAX helps to probiotic consisting of four reduce gastro-intestinal bacterial strains discomfort

Q-2008-444

Commission Regulation (EC) No Non-authorised 984/2009 of 21/10/2009

N/A

Art.13(5) Lactobacillus rhamnosus GG (LGG)

Lactobacillus GG helps to maintain defence against intestinal pathogens Lactobacillus plantarum 299v (DSM 9843) improves iron absorption NPU Tablets imitate female breasts enhancement process by 8-PN (8Prenylnaringenin)

Q-2010-01028

Commission Regulation (EU) No Non-authorised 379/2012 of 03/05/2012

N/A

Art.13(5) Lactobacillus plantarum 299v (DSM 9843)

Q-2008-785

Commission Regulation (EU) No Non-authorised 375/2010 of 03/05/2010

N/A

Art.13(5) Natural Push-Up Tablets and Natural PushUpCapsules containing hops

Q-2008-784

Commission Regulation (EU) No Non-authorised 382/2010 of 05/05/2010

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Lactobacillus plantarum TENSIA

Regular consumption Non-compliance with the Regulation (at least three weeks) of because on the basis of the scientific 50 g/day Sdamejuust evidence assessed,<br />this claimed ('heart cheese') of effect for this food has not been Harmony brand substantiated comprising probiotic Lactobacillus plantarum TENSIA helps to maintain the cardiovascular system/heart health through reduction of blood pressure /symbol of heart Art.13(5) Saccharomyces cerevisiae Saccharomyces Non-compliance with the Regulation var. boulardii CNCM I-3799 cerevisiae var. boulardii because on the basis of the scientific CNCM I-3799 helps evidence assessed,<br />this claimed maintain effect for this food has not been intestinal&nbsp;comfort substantiated Art.13(5) Ethanol-water extract of Slimaluma helps to Non-compliance with the Regulation Caralluma fimbriata control hunger/appetite because on the basis of the scientific (Slimaluma) evidence assessed,<br />this claimed effect for this food has not been substantiated Art.13(5) Ethanol-water extract of Slimaluma helps to Non-compliance with the Regulation Caralluma fimbriata reduce body fat because on the basis of the scientific (Slimaluma) evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2010-00950

Commission Regulation (EU) 1171/2011 of 16/11/2011

Non-authorised

N/A

Q-2012-00271

Commission Regulation (EU) No Non-authorised N/A 1066/2013 of 30/10/2013 (expiry of transitional period 20/05/2014) Commission Regulation (EU) 432/2011 of 04/05/2011 Non-authorised N/A

Q-2010-00031

Q-2010-00028

Commission Regulation (EU) 432/2011 of 04/05/2011

Non-authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Ethanol-water extract of Caralluma fimbriata (Slimaluma)

Art.13(5)

Art.13(5)

Art.13(5)

Art.13(5)

Art.13(5)

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Ethanol-water extract of Slimaluma helps to Non-compliance with the Regulation Caralluma fimbriata reduce caloric intake because on the basis of the scientific (Slimaluma) evidence assessed,<br />this claimed effect for this food has not been substantiated Ethanol-water extract of Slimaluma helps to Non-compliance with the Regulation Caralluma fimbriata reduce waist because on the basis of the scientific (Slimaluma) circumference evidence assessed,<br />this claimed effect for this food has not been substantiated Spermidine Spermidine&nbsp;prolo this claimed effect relates to the ngs the growing phase treatment of a disease which is (anagen) of the hair prohibited for foods<br />Noncycle compliance with the Regulation because on the basis of the scientific evidence assessed, Sugar beet fibre Sugar beet fibre Non-compliance with the Regulation decreases intestinal because on the basis of the scientific transit time evidence assessed,<br />this claimed effect for this food has not been substantiated Silymarin BIO-C, an Suggested for Non-compliance with the Regulation extract of milk thistle improving the because on the basis of the scientific (Silybum marianum (L.) physiological production evidence assessed,<br />this claimed Gaertn.) seeds (dry extract of breast milk during effect for this food has not been standardised to 40-80 % breast feeding substantiated silymarin)

Slimaluma helps to reduce body weight

Q-2010-00029

Commission Regulation (EU) 432/2011 of 04/05/2011

Non-authorised

N/A

Q-2010-00030

Commission Regulation (EU) 432/2011 of 04/05/2011

Non-authorised

N/A

Q-2010-00027

Commission Regulation (EU) 432/2011 of 04/05/2011

Non-authorised

N/A

Q-2011-00896

Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014)

Q-2011-00971

Commission Regulation (EU) No Non-authorised N/A 1017/2013 of 23/10/2013 (expiry of transitional period 13/05/2014) Commission Regulation (EU) 666/2011 of 11/07/2011 Non-authorised N/A

Q-2009-00957

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.13(5) Bimuno (BGOS) Prebiotic, Supports your natural a -galacto-oligosaccharidedefences mixture

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Art.13(5) Synbio, a combination of Synbio persists in the Non-compliance with the Regulation two probiotic bacterial intestinal tract and because on the basis of the scientific strains Lactobacillus favours the natural evidence assessed,<br />this claimed rhamnosus IMC 501 and regularity contributing to effect for this food has not been Lactobacillus paracasei maintain and improve substantiated IMC 502 human intestinal wellbeing Art.13(5) Immune Balance Drink, The Immune Balance Non-compliance with the Regulation containing vitamin C, green Drink activates body's because on the basis of the scientific tea extract, grape skin defence evidence assessed,<br />this claimed extract, grape seed extract, effect for this food has not been and shiitake mushroom substantiated extract Art.13(5) Milk product, rich in fibre This product reduces Non-compliance with the Regulation and protein the sense of hunger because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2009-00230

Commission Regulation (EU) No Non-authorised 382/2010 of 05/05/2010

N/A

Q-2009-00889

Commission Regulation (EU) 666/2011 of 11/07/2011

Non-authorised

N/A

Q-2009-517

Commission Regulation (EU) No Non-authorised 958/2010 of 22/10/2010

N/A

Q-2008-396

Commission Regulation (EU) No Non-authorised 383/2010 of 05/05/2010

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Uroval, food supplement Cranberry extract and D Non-compliance with the Regulation a) containing cranberry -mannose, the main because on the basis of the scientific extract and D-mannose active ingredients of the evidence assessed,<br />this claimed food supplement effect for this food has not been Uroval, eliminate the substantiated adhesion of harmful bacteria to the bladder wall. The adhesion of harmful bacteria to the bladder wall is the main risk factor in the development of urinary tract infections Art.14(1)( Lactobacillus helveticus Evolus reduces Non-compliance with the Regulation a) fermented Evolus low-fat arterial stiffness. because on the basis of the scientific milk products evidence assessed,<br />this claimed effect for this food has not been substantiated Art.14(1)( ACTIMEL Lactobacillus Fermented milk Non-compliance with the Regulation a) casei DN-114 001 plus containing the probiotic because on the basis of the scientific yoghurt symbiosis Lactobacillus casei DN- evidence assessed,<br />the evidence 114 001 and yoghurt provided is insufficient to substantiate symbiosis decreases this claimed effect for this food presence of Clostridium difficile toxins in the gut (of susceptible ageing people). Presence of Clostridium difficile toxins is associated with the incidence of acute diarrhoea

Q-2009-00600

Commission Regulation (EU) No Non-authorised 957/2010 of 22/10/2010

N/A

Q-2008-218

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Q-2009-00776

Commission Regulation (EU) 1160/2011 of 14/11/2011

Non-authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Lycopene-whey complex a)

Lycopene-whey complex prevents oxidative damage of plasma lipoproteins, which reduces the build up of arterial plaques and reduces the risk of heart disease, stroke and other clinical complications of atherosclerosis Art.14(1)( NeOpuntia, containing NeOpuntia helps to a) dehydrated leaves of the improve blood lipid prickly pear cactus parameters associated (Opuntia ficus-indica) with cardiovascular risks, especially the HDL-cholesterol. Art.14(1)( OPC Plus, containing 40 OPC Plus has been a) mg oligomeric procyanidins shown to increase the (OPC) and 40 mg berry- microcirculation and blend per capsule may therefore reduce the risk of chronic venous insufficiency

Q-2008-703

Commission Regulation (EU) 384/2010 of 05/05/2010

Non-authorised

N/A

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food is not a beneficial physiological effect as required by the Regulation and could not therefore be substantiated

Q-2008-214

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Q-2009-00751

Commission Regulation (EU) 665/2011 of 11/07/2011

Non-authorised

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( OPC Premium, containing a) 40 mg oligomeric procyanidins (OPC) and 400 mg berry-blend per capsule

OPC have been shown to reduce blood cholesterol levels and may therefore reduce the risk of cardiovascular disease

Art.14(1)( ProteQuine, a low a) molecular weight fraction from bovine blood

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />the food for which the claim is made has not been sufficiently characterised with respect to the berry blend, whereas the active constituent extracted from grape (Vitis vinifera) seeds is sufficiently characterised<br />this claimed effect for this food has not been substantiated ProteQuine Non-compliance with the Regulation elevates/maintains the because on the basis of the scientific level of ScIgA on evidence assessed,<br />this claimed mucous membranes. effect for this food has not been Decreased or substantiated insufficient level of ScIgA is a risk factor in the development of common cold or influenza

Q-2009-00454

Commission Regulation (EU) No Non-authorised 957/2010 of 22/10/2010

N/A

Q-2008-397

Commission Regulation (EU) No Non-authorised 378/2012 of 03/05/2012

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( ProteQuine, a low a) molecular weight fraction from bovine blood, in combination with bovine lactoferrin

Art.14(1)( Calcium-containing fruit a) juices

ProteQuine in Non-compliance with the Regulation combination with bovine because on the basis of the scientific lactoferrin evidence assessed,<br />this claimed elevates/maintains the effect for this food has not been level of ScIgA on substantiated mucous membranes. Decreased or insufficient level of ScIgA is a risk factor in the development of common cold with sore throat and combination of ProteQuine with bovine lactoferrin reduces the risk of the development of sore throat Reduced risk for dental Non-compliance with the Regulation erosion because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-398

Commission Regulation (EU) No Non-authorised 378/2012 of 03/05/2012

N/A

Q-2009-00501

Commission Regulation (EU) 1170/2011 of 16/11/2011

Non-authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Ocean Spray Cranberry Regular consumption of Non-compliance with the Regulation a) Products, juice drinks and2 servings per day of an because on the basis of the scientific sweetened dried berries Ocean Spray product evidence assessed,<br />this claimed Craisins each containing effect for this food has not been typically 80 mg substantiated cranberry proanthocyanidins helps reduce the risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract Art.14(1)( Bimuno (BGOS) Prebiotic, Regular consumption of Non-compliance with the Regulation a) a -galacto-oligosaccharideBimuno (BGOS) because on the basis of the scientific mixture Prebiotic helps to evidence assessed,<br />this claimed protect against the bad effect for this food has not been bacteria than can cause substantiated the travellers diarrhoea Art.14(1)( Water a) Regular consumption of Non-compliance with the Regulation significant amounts of because on the basis of the scientific water can reduce the evidence assessed,<br />the proposed risk of development of risk factors are measures of the dehydration and of disease and a risk factor in the concomitant decrease development of a disease is not shown of performance to be reduced

Q-2008-117

Commission Regulation (EC) No Non-authorised 1167/2009 of 30/11/2009

N/A

Q-2009-00232

Commission Regulation (EU) 384/2010 of 05/05/2010

Non-authorised

N/A

Q-2008-05014

Commission Regulation (EU) 1170/2011 of 16/11/2011

Non-authorised

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Soy protein a)

Soy protein has been Non-compliance with the Regulation shown to lower/reduce because on the basis of the scientific blood cholesterol; blood evidence assessed,<br />this claimed cholesterol lowering effect for this food has not been may reduce the risk of substantiated (coronary) heart disease Art.14(1)( Melgao naturally The regular Non-compliance with the Regulation a) sparkling mineral water consumption of because on the basis of the scientific Melgao mineral water evidence assessed,<br />this claimed reduces body effect for this food has not been hyperglycaemic levels substantiated Art.14(1)( Follow-on formulae with a Aids minor intestinal Non-compliance with the Regulation b) fixed combination of short- ailments (as colic, because on the basis of the scientific chain galactoconstipation, digestive evidence assessed,<br />this claimed oligosaccharides, acidified symptoms) effect for this food has not been milk, nucleotides and betasubstantiated palmitate Art.14(1)( Beta-palmitate Beta-palmitate Non-compliance with the Regulation b) enrichment contributes because on the basis of the scientific to increase calcium evidence assessed,<br />the evidence absorption provided is insufficient to substantiate this claimed effect for this food Art.14(1)( I omega kids/Pufan 3 b) kids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) Calming Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2009-00672

Commission Regulation (EU) 1160/2011 of 14/11/2011

Non-authorised

N/A

Q-2008-219

Commission Regulation (EC) No Non-authorised 1167/2009 of 30/11/2009

N/A

Q-2008-270

Commission Regulation (EC) No Non-authorised 1167/2009 of 30/11/2009

N/A

Q-2008-172

Commission Regulation (EU) No Non-authorised 378/2012 of 03/05/2012

N/A

Q-2008-091 Q-2008-096 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

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Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Docosahexaenoic Acid b) (DHA) and Arachidonic Acid (ARA)

Art.14(1)( Dairy products (milk and b) cheese)

Art.14(1)( Docosahexaenoic Acid b) (DHA) and Arachidonic Acid (ARA)

Art.14(1)( Efalex products, b) containing eicosapentaenoic acid (EPA), the n-6 PUFA gamma-linolenic acid (GLA) and Arachidonic Acid (ARA)

DHA & ARA support Non-compliance with the Regulation neural development of because on the basis of the scientific the brain and eyes. evidence assessed,<br />this claimed effect for this food has not been substantiated Dairy foods (milk and Non-compliance with the Regulation cheese) promote dental because on the basis of the scientific health in children. evidence assessed,<br />this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated Docosahexaenoic acid Non-compliance with the Regulation (DHA) and arachidonic because on the basis of the scientific acid (ARA) contribute to evidence assessed,<br />the evidence the optimal brain provided did not allow the development of infants establishment of conditions of use in and young children accordance with Art. 16(4) of Regulation 1924/2006, and the claim could not therefore be authorised Efalex may help Non-compliance with the Regulation maintain and support because on the basis of the scientific brain development and evidence assessed,<br />this claimed function effect for this food has not been substantiated

Q-2008-120

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Q-2008-112

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Q-2008-212

Commission Regulation (EU) No Non-authorised 440/2011 of 06/05/2011

N/A

Q-2008-318

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation as, on the basis of the evidence presented in the dossier,<br />this claimed effect for this food has not been substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Efalex products, b) containing eicosapentaenoic acid (EPA), the n-6 PUFA gamma-linolenic acid (GLA) and Arachidonic Acid (ARA) Art.14(1)( Efalex products, b) containing eicosapentaenoic acid (EPA), the n-6 PUFA gamma-linolenic acid (GLA) and Arachidonic Acid (ARA) Art.14(1)( Efalex products, b) containing eicosapentaenoic acid (EPA), the n-6 PUFA gamma-linolenic acid (GLA) and Arachidonic Acid (ARA) Art.14(1)( Efalex products, b) containing eicosapentaenoic acid (EPA), the n-6 PUFA gamma-linolenic acid (GLA) and Arachidonic Acid (ARA)

Efalex may help maintain and support eye development and function.

Q-2008-320

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Efalex may help Non-compliance with the Regulation maintain concentration. because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-317

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Efalex may help maintain coordination.

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-121

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Efalex may help Non-compliance with the Regulation maintain learning ability because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-319

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

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Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Enfamil Premium, Enfamil Premium b) containing contributes to optimal docosahexaenoic acid brain development of (DHA) and arachidonic acidinfants and young (ARA) children

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />the evidence provided did not allow the establishment of conditions of use in accordance with Art. 16(4) of Regulation 1924/2006, and the claim could not therefore be authorised Art.14(1)( Eye q baby, containing a Eye q baby provides Non-compliance with the Regulation b) combination of the n-3 the nourishments that because on the basis of the scientific polyunsaturated fatty acids support healthy central evidence assessed,<br />this claimed (PUFAs) eicosapentaenoic nervous system effect for this food has not been acid (EPA) and development substantiated docosahexaenoic acid (DHA) and the n-6 PUFA gamma-linolenic acid (GLA) Art.14(1)( Eye q, containing a Eye q (a unique Non-compliance with the Regulation b) combination of combination of Highbecause on the basis of the scientific eicosapentaenoic acid, EPA/DHA/GLA omega- evidence assessed,<br />the evidence docosahexaenoic acid, and 3, 6 PUFA) provides the provided is insufficient to substantiate gamma-linolenic acid essential nutrients that this claimed effect for this food helps improve working memory in children

Q-2008-691

Commission Regulation (EU) No Non-authorised 440/2011 of 06/05/2011

N/A

Q-2008-119

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Q-2009-00485

Commission Regulation (EU) No Non-authorised 1162/2010 of 09/12/2010

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Eye q baby, containing a Eye q provides the b) combination of the n-3 nourishment that help polyunsaturated fatty acids children to maintain (PUFAs) eicosapentaenoic concentration levels acid (EPA) and docosahexaenoic acid (DHA) and the n-6 PUFA gamma-linolenic acid (GLA) Art.14(1)( Eye q baby, containing a Eye q provides the b) combination of the n-3 nourishments that help polyunsaturated fatty acids to maintain healthy (PUFAs) eicosapentaenoic brain functions acid (EPA) and docosahexaenoic acid (DHA) and the n-6 PUFA gamma-linolenic acid (GLA) Art.14(1)( I omega kids/Pufan 3 Help to promote b) kids containing concentration docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) Art.14(1)( I omega kids/Pufan 3 Help to support mental b) kids containing development docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)

Q-2008-330

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated

Q-2008-329

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-094 Q-2008-099 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Q-2008-098 Q-2008-104 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

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Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />the evidence provided is insufficient to substantiate this claimed effect for this food

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( I omega kids/Pufan 3 b) kids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) Art.14(1)( I omega kids/Pufan 3 b) kids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) Art.14(1)( I omega kids/Pufan 3 b) kids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)

Help to support the learning ability

Q-2008-102 Q-2008-103 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Help to support vision

Q-2008-095 Q-2008-100 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Helps to promote the thinking capacity

Q-2008-093 Q-2008-101 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Art.14(1)( Immunofortis, a mixture ofImmunofortis to b) short-chain galactonaturally strengthen oligosaccharides and long- your babys immune chain fructosystem oligosaccharides Art.14(1)( Kinder Chocolate, b) chocolate bar

Q-2008-106

Commission Regulation (EU) No Non-authorised 1162/2010 of 09/12/2010

N/A

Kinder Chocolate, the Non-compliance with the Regulation chocolate that helps to because on the basis of the scientific grow evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-283

Commission Regulation (EC) No Non-authorised 1167/2009 of 30/11/2009

N/A

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this food is not sufficiently characterised for a scientific assessment of this claimed effect and<br />this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( LACTORAL, food b) supplement containing Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium longum

LACTORAL contains living probiotic bacteria with strong ability to intestinal tract colonisation, isolated from healthy, naturally fed-infant

Q-2008-480

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Art.14(1)( LACTORAL, food b) supplement containing Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium longum

Art.14(1)( LACTORAL, food b) supplement containing Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium longum

LACTORAL helps to Non-compliance with the Regulation bring back the normal because on the basis of the scientific functioning of the evidence assessed,<br />this food is alimentary tract during not sufficiently characterised for a its microflora scientific assessment of this claimed disturbances (for effect and<br />this claimed effect for example in case of this food is not sufficiently defined to loose stools, after taking be able to be assessed and the claim antibiotics, in case of could not therefore be substantiated intestinal disorders caused by enteric pathogens). LACTORAL helps to Non-compliance with the Regulation maintain natural because on the basis of the scientific intestinal microflora evidence assessed,<br />this food is during travel, changing not sufficiently characterised for a the climatic zone or a scientific assessment of this claimed diet, especially in poor effect and<br />this claimed effect for hygiene conditions. this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated

Q-2008-269

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Q-2008-479

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( LACTORAL, food b) supplement containing Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium longum

Art.14(1)( LACTORAL, food b) supplement containing Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium longum

LACTORAL helps to Non-compliance with the Regulation protect the alimentary because on the basis of the scientific system against enteric evidence assessed,<br />this food is pathogens because of not sufficiently characterised for a strong antagonistic scientific assessment of this claimed properties and helps to effect and the claim could not therefore build the natural be substantiated intestinal barrier. LACTORAL is Non-compliance with the Regulation recommended in order because on the basis of the scientific to improve the general evidence assessed,<br />this food is immunity by maintaining not sufficiently characterised for a the microbiological scientific assessment of this claimed balance. effect and<br />this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />the evidence provided did not allow the establishment of conditions of use in accordance with Art. 16(4) of Regulation 1924/2006, and the claim could not therefore be authorised Non-compliance with the Regulation because on the basis of the scientific evidence assessed,<br />this claimed effect for this food has not been substantiated

Q-2008-478

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Q-2008-477

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Art.14(1)( Lipil, containing Lipil contributes to b) docosahexaenoic acid optimal brain (DHA) and arachidonic aciddevelopment of infants (ARA) from single cell oils and young children

Q-2008-690

Commission Regulation (EU) No Non-authorised 440/2011 of 06/05/2011

N/A

Art.14(1)( Lactobacillus delbrueckii Maintaining the gut b) subsp. bulgaricus strain health by normalizing AY/CSL (LMG P-17224) the intestinal flora and Streptococcus thermophilus strain 9Y/CSL (LMG P-17225)

Q-2008-273

Commission Regulation (EU) No Non-authorised 378/2012 of 03/05/2012

N/A

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( Mumomega, containing a Mumomega provides Non-compliance with the Regulation b) combination of the n-3 the nourishments that because on the basis of the scientific polyunsaturated fatty acids support healthy central evidence assessed,<br />this claimed (PUFAs) eicosapentaenoic nervous system effect for this food has not been acid (EPA) and development. substantiated docosahexaenoic acid (DHA) and the n-6 PUFA gamma-linolenic acid (GLA) Art.14(1)( Mixture of bifidobacteria Probiotic bifidobacteria Non-compliance with the Regulation b) (Bifidobacterium bifidum, lead to a healthy because on the basis of the scientific Bifidobacterium breve, intestinal flora evidence assessed,<br />this food is Bifidobacterium infantis, comparable to the not sufficiently characterised for a Bifidobacterium longum) composition of the scientific assessment of this claimed intestinal flora of breast- effect and the claim could not therefore fed infants intestine be substantiated Art.14(1)( I omega kids/Pufan 3 Provide serenity and Non-compliance with the Regulation b) kids containing room for a beneficial because on the basis of the scientific docosahexaenoic acid development of the evidence assessed,<br />this claimed (DHA) and child effect for this food is not sufficiently eicosapentaenoic acid defined to be able to be assessed and (EPA) the claim could not therefore be substantiated Art.14(1)( Dairy products (milk, Three portions of dairy Non-compliance with the Regulation b) cheese and yoghurt) food everyday, as part because on the basis of the scientific of a balanced diet, may evidence assessed,<br />this food is help promote a healthy not sufficiently characterised for a body weight during scientific assessment of this claimed childhood and effect and the claim could not therefore adolescence. be substantiated

Q-2008-328

Commission Regulation (EC) No Non-authorised 1024/2009 of 29/10/2009

N/A

Q-2009-00224

Commission Regulation (EU) No Non-authorised 957/2010 of 22/10/2010

N/A

Q-2008-092 Q-2008-097 Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Q-2008-110

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

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EU Register on nutrition and health claims

Claim type

Nutrient, substance, food or food category

Claim

Conditions of use of the claim / Restrictions of use / Reasons for non-authorisation

Health relationship

EFSA opinion reference Commission regulation

Status

Entry Id

Art.14(1)( regulat.pro.kid IMMUN, b) food supplement with fermented vegetables and fruits, probiotics lecithin and rhodiola rosea extract

regulat.pro.kid IMMUN Non-compliance with the Regulation supports, stimulates because on the basis of the scientific and modulates the evidence assessed,<br />this food is immune system of not sufficiently characterised for a children during growth. scientific assessment of this claimed effect and<br />this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated regulat.pro.kid.BRAIN Non-compliance with the Regulation contributes to mental because on the basis of the scientific and cognitive evidence assessed,<br />this food is development of children not sufficiently characterised for a scientific assessment of this claimed effect and<br />this claimed effect for this food is not sufficiently defined to be able to be assessed and the claim could not therefore be substantiated

Q-2008-082

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Art.14(1)( regulat.pro.kid.BRAIN, b) food supplement with probiotics and fermented vegetables and fruits

Q-2008-083

Commission Regulation (EC) 983/2009 of 21/10/2009

Non-authorised

N/A

Claims whose status is marked with a * indicate a claim for which protection of proprietary data is granted (and for which the right of use of the claim is restricted to the benefit of the applicant). For further information please go to: http://ec.europa.eu/nuhclaims/?event=getListOfPropClaims

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